Apparatus and method for fabricating a customized patient-specific orthopaedic instrument

ABSTRACT

A number of orthopaedic surgical instruments are also disclosed. A method, apparatus, and system for fabricating such instruments are also disclosed.

The present application is a continuation application of U.S. patentapplication Ser. No. 12/241,001 entitled “Apparatus and Method forFabricating a Customized Patient-Specific Orthopaedic Instrument,” whichwas filed on Sep. 29, 2008 by Bryan Rose et al., which claims priorityunder 35 U.S.C. § 119(e) to U.S. Provisional Patent Application Ser. No.60/976,447 entitled “Method and Apparatus for Fabricating CustomizedPatent Instrumentation,” which was filed on Sep. 30, 2007 by Dan Augeret al.; U.S. Provisional Patent Application Ser. No. 60/976,448 entitled“Adjustable Customized Patient-Specific Orthopaedic SurgicalInstrumentation,” which was filed on Sep. 30, 2007 by Luke Aram et al.;U.S. Provisional Patent Application Ser. No. 60/976,451 entitled“Customized Patient-Specific Instrumentation For Use In OrthopaedicSurgical Procedures,” which was filed on Sep. 30, 2007 by Jeff Roose etal.; U.S. Provisional Patent Application Ser. No. 60/976,444 entitled“Method and Apparatus for Patient-Specific Positioning of OrthopaedicSurgical Instrumentation,” which was filed on Sep. 30, 2007 by Luke Aramet al.; and U.S. Provisional Patent Application Ser. No. 60/976,446entitled “Method and Apparatus for Aligning Customized Patient-SpecificOrthopaedic Surgical Instruments,” which was filed on Sep. 30, 2007 byLuke Aram et al., each of which is assigned to the same assignee as thepresent application, and each of which is hereby incorporated byreference.

CROSS-REFERENCE TO RELATED U.S. PATENT APPLICATIONS

Cross-reference is made to U.S. Utility patent application Ser. No.12/240,985, now U.S. Pat. No. 8,357,166, entitled “CustomizedPatient-Specific Instrumentation And Method For Performing A BoneRe-cut,” which was filed by Luke Aram et al.; U.S. Utility patentapplication Ser. No. 12/240,990, now U.S. Pat. No. 8,425,523, entitled“Customized Patient-Specific Instrumentation for Use In OrthopaedicSurgical Procedures,” which was filed by Luke Aram et al.; U.S. Utilitypatent application Ser. No. 12/240,988, now U.S. Pat. No. 8,343,159,entitled “Orthopaedic Bone Saw And Method of Use Thereof,” which wasfiled by Travis Bennett; U.S. Utility patent application Ser. No.12/240,992, now U.S. Pat. No. 8,323,288, entitled “CustomizedPatient-Specific Bone Cutting Blocks,” which was filed by Eric Zajac;U.S. Utility patent application Ser. No. 12/240,994, now U.S. Pat. No.8,425,524, entitled “Customized Patient-Specific Multi-Cutting Blocks,”which was filed by Christopher Aker et al.; U.S. Utility patentapplication Ser. No. 12/240,996, now U.S. Pat. No. 8,419,740, entitled“Customized Patient-Specific Bone Cutting Instrumentation,” which wasfiled by Luke Aram et al.; U.S. Utility patent application Ser. No.12/240,997, now U.S. Pat. No. 8,398,645, entitled “Femoral/TibialCustomized Patient Specific Orthopaedic Surgical Instrumentation,” whichwas filed by Christopher Aker et al.; U.S. Utility patent applicationSer. No. 12/240,998, now U.S. Pat. No. 8,377,068, entitled “AdjustableCustomized Patient-Specific Orthopaedic Surgical Instrumentation,” whichwas filed by Christopher Aker et al.; U.S. Utility patent applicationSer. No. 12/241,006, now U.S. Pat. No. 8,594,395, entitled “System andMethod For Fabricating A Customized Patient-Specific SurgicalInstrument,” which was filed by Jeff Roose et al.; U.S. Utility patentapplication Ser. No. 12/241,002, now abandoned, entitled “CustomizedPatient-Specific Bone Cutting Block With External Reference,” which wasfiled by Luke Aram et al.; and U.S. Utility patent application Ser. No.12/240,999, now U.S. Pat. No. 8,361,076, entitled “Patient-CustomizableDevice And System For Performing An Orthopaedic Surgical Procedures,”which was filed by Jeff Roose, each of which is assigned to the sameassignee as the present application, each of which is filed concurrentlyherewith, and each of which is hereby incorporated by reference.

TECHNICAL FIELD

The present disclosure relates generally to customized patient-specificorthopaedic surgical instruments and to methods, devices, and systemsfor fabricating and positioning such instruments.

BACKGROUND

Joint arthroplasty is a well-known surgical procedure by which adiseased and/or damaged natural joint is replaced by a prosthetic joint.A typical knee prosthesis includes a tibial tray, a femoral component, apolymer insert or bearing positioned between the tibial tray and thefemoral component, and, in some cases, a polymer patella button. Tofacilitate the replacement of the natural joint with the kneeprosthesis, orthopaedic surgeons use a variety of orthopaedic surgicalinstruments such as, for example, cutting blocks, drill guides, millingguides, and other surgical instruments. Typically, the orthopaedicsurgical instruments are generic with respect to the patient such thatthe same orthopaedic surgical instrument may be used on a number ofdifferent patients during similar orthopaedic surgical procedures.

SUMMARY

According to one aspect, a method of performing an orthopaedic surgicalprocedure on a bone of a patient is disclosed. The method may includepositioning a customized patient-specific cutting block in contact withthe bone of a patient. In some embodiments, the method may includepositioning the customized patient-specific cutting block in contactwith a femur of the patient. In some embodiments, the method may includepositioning the customized patient-specific cutting block in contactwith a tibia of the patient. The method may include inserting a pair ofguide pins into a pair of guide pin holes defined in the customizedpatient-specific cutting block. The method may also include making afirst cut in the bone of the patient with the customizedpatient-specific cutting block. In some embodiments, the method mayinclude making the first cut in the femur of the patient with thecustomized patient-specific cutting block. In other embodiments, themethod may include making the first cut in the tibia of the patient withthe customized patient-specific cutting block. The method may alsoinclude removing the customized patient-specific cutting block from thebone of the patient without removing the guide pins from the bone of thepatient.

The method may include inserting the pair of guide pins into a pair ofguide pin holes defined in a patient-universal re-cut block and making asecond cut in the bone of the patient with the patient-universal re-cutblock. In some embodiments, the method may include making the second cutin the femur of the patient with the patient-universal re-cut block. Themethod may also include making the second cut in the femur of thepatient substantially parallel to the first cut. Additionally, in someembodiments, the method may include making the second cut in the femuroriented in an angled position relative to the first cut.

In some embodiments, the method may include making the second cut in thetibia of the patient with the patient-universal re-cut block. The methodmay include making the second cut in the tibia of the patientsubstantially parallel to the first cut. Additionally, in someembodiments, the method may include making the second cut in the tibiaoriented in an angled position relative to the first cut.

In some embodiments, the method may include inserting the pair of guidepins into the pair of guide pin holes defined in the patient-universalre-cut block such that a cutting guide of the patient-universal re-cutblock is substantially parallel to the first cut. The method may includemaking the second cut in the bone of the patient with thepatient-universal re-cut block such that the second cut is substantiallyparallel to the first cut. Additionally, in some embodiments, thecutting guide of the patient-universal re-cut block may be oriented inan angled position relative to the first cut. The method may includemaking the second cut in the bone of the patient with thepatient-universal re-cut block such that the second cut is oriented inan angled position relative to the first cut.

In some embodiments, the method may include determining an amount ofadditional bone to be removed from the bone of the patient subsequent tomaking the first cut in the bone of the patient with the customizedpatient-specific cutting block. The method may include selecting a pairof guide pin holes from a plurality of pairs of guide pin holes definedin the patient-universal re-cut block that corresponds to the amount ofadditional bone to be removed from the bone of a patient. The method mayinclude inserting the pair of guide pins into the selected pair of guidepin holes defined in the patient-universal re-cut block that correspondsto the amount of additional bone to be removed from the bone of apatient.

According to another aspect, an orthopaedic instrument assembly mayinclude a customized patient-specific cutting block and apatient-universal re-cut block. In some embodiments, the customizedpatient-specific cutting block may be a patient-specific femoral cuttingblock and the patient-universal re-cut block may be a patient-universalfemoral re-cut block. In other embodiments, the customizedpatient-specific cutting block may be a patient-specific tibial cuttingblock and the patient-universal re-cut block may be a patient-universalfemoral re-cut block.

The customized patient-specific cutting block may include a cuttingguide and a pair of guide pin holes. The patient-universal re-cut blockmay include a cutting guide and a plurality of pairs of guide pin holes.Each pair of guide pin holes of patient-universal re-cut block maycorrespond in diameter and spacing with the pair of guide pin holes ofthe customized patient-specific cutting block.

In some embodiments, the cutting guide of the patient-universal re-cutblock may be substantially parallel to the cutting guide of thecustomized patient-specific cutting block when a one pair of guide pinholes of the patient universal re-cut block is aligned with the pair ofguide pin holes of the customized patient-specific cutting block. Insome embodiments, the cutting guide of the patient-universal re-cutblock may be oriented in an angled position relative to the cuttingguide of the customized patient-specific cutting block when a one pairof guide pin holes of the patient universal re-cut block is aligned withthe pair of guide pin holes of the customized patient-specific cuttingblock.

In another aspect, a method of performing an orthopaedic surgicalprocedure on a femur of a patient is disclosed. The method may includepositioning or placing a customized patient-specific cutting block incontact with the femur of the patient and inserting a pair of guide pinsinto a pair of guide pin holes defined in the customizedpatient-specific cutting block. The method may also include making afirst cut in the femur of the patient with the customizedpatient-specific cutting block. The method may include removing thecustomized patient-specific cutting block without removing the guidepins from the femur of the patient. The method may also includedetermining an amount of additional bone to be removed from the femur ofthe patient subsequent to making the first cut in the femur andselecting a pair of guide pin holes from a plurality of pairs of guidepin holes defined in a patient-universal re-cut block which correspondsto the amount of additional bone to be removed from the femur of thepatient.

The method may further include inserting the pair of guide pins into theselected pair of guide pin holes defined in the patient-universal re-cutblock which corresponds to the amount of additional bone to be removedfrom the femur of the patient. The method may include making a secondcut in the femur of the patient with the patient-universal re-cut block.In some embodiments, the method may include inserting the pair of guidepins into the selected pair of guide pin holes such that a cutting guideof the patient-universal re-cut block is substantially parallel to thefirst cut. The method may include making the second cut in the femur ofthe patient with the patient-universal re-cut block such that the secondcut is substantially parallel to the first cut. Additionally, in someembodiments, the method may include inserting the pair of guide pinsinto the selected pair of guide pin holes such that a cutting guide ofthe patient-universal re-cut block is oriented in an angled positionrelative to the first cut. The method may include making the second cutin the femur of the patient with the patient-universal re-cut block suchthat the second cut is oriented in an angled position relative to thefirst cut.

According to one aspect, an orthopaedic bone saw for cutting the bone ofa patient is disclosed. The orthopaedic bone saw may include a chuckconfigured to receive a bone saw blade and a guide configured to receiveone or more surgical guide pins to align the bone saw in a predeterminedposition relative to the bone of the patient. In some embodiments, theguide may include a body having one or more openings to receive the oneor more surgical guide pins. Additionally, in some embodiments, theguide may have an elongated body with a slot, and the slot may beconfigured to receive the one or more surgical guide pins.

In some embodiments, the orthopaedic bone saw may have a swivel securedto the guide that permits the chuck and the guide to swivel relative toone another. In some embodiments, the orthopaedic bone saw may have ahandle and a housing secured to the handle. The chuck may be secured tothe housing, and the swivel may be positioned between the housing andthe guide. The guide may swivel relative to the housing. In someembodiments, both the chuck and the guide may be secured to the housing.

According to another aspect, an orthopaedic bone saw tool for cuttingthe bone of a patient is disclosed. The orthopaedic bone saw tool mayinclude a bone saw and a bone saw blade. The bone saw may have ahousing, a handle secured to the housing, and a chuck secured to thehousing. The bone saw blade may be secured to the chuck.

The bone saw may include a guide secured to the housing that isconfigured to receive one or more surgical guide pins. In someembodiments, the guide may have a body that has one or more openings toreceive the one or more surgical guide pins. In some embodiments, theguide may have an elongated body that has a slot. The slot may beconfigured to receive the one or more surgical guide pins. In someembodiments, the bone saw may include a swivel positioned between thehousing and the guide. The swivel may permit the guide and the bone sawblade to swivel relative to one another.

According to another aspect, a method of performing an orthopaedicsurgical procedure on a bone of a patient is disclosed. The method mayinclude inserting a first end of one or more surgical guide pins intothe bone of the patient. The method may also include advancing a secondend of the one or more surgical guide pins into a guide secured to abone saw so as to position the bone saw in a predetermined positionrelative to the bone of the patient. The method may include making a cutin the bone of the patient with the bone saw while the one or moresurgical guide pins are positioned in the guide.

In some embodiments, the guide may have a body having one or moreopenings defined therein. The method may include advancing the secondend of the one or more surgical guide pins into the one or more openingsof the body of the guide. Additionally, in some embodiments, the guidemay include an elongated body having a slot. The method may includeadvancing the second end of the one or more surgical guide pins into theslot of the elongated body of the guide.

In some embodiments, the bone saw may include a bone saw blade securedto chuck and a swivel positioned between the chuck and the guide. Themethod may include swiveling the chuck relative the guide while makingthe cut in the bone of the patient.

In some embodiments, the method may include positioning a customizedpatient-specific cutting block in contact with the bone of the patient.The method may also include inserting the first end of the one or moresurgical guide pins through one or more guide pin holes defined in thecustomized patient-specific cutting block and into the bone of thepatient. The method may further include removing the customizedpatient-specific cutting block from the bone of the patient withoutremoving the one or more surgical guide pins from the bone of thepatient.

According to one aspect, a customized patient-specific orthopaedicinstrument is disclosed. The customized patient-specific orthopaedicinstrument may include a customized patient-specific femoral cuttingblock that may include a body having a bone-facing surface having acustomized patient-specific negative contour configured to receive aportion of an anterior side of a patient's femur that has acorresponding positive contour. The customized patient-specificorthopaedic instrument may also include at least one tab extendingposteriorly from the body, the at least one tab having a bone-facingsurface having a customized patient-specific negative contour configuredto receive a portion of the distal side of the patient's femur that hasa corresponding positive contour. The customized patient-specificorthopaedic instrument may include a lip extending superiorly from anend of the at least one tab, the lip having a bone-facing surface havinga customized patient-specific negative contour configured to receive aportion of the posterior side of the patient's femur that has acorresponding position contour.

In some embodiments, the customized patient-specific femoral cuttingblock may include a first tab extending posteriorly from the body and asecond tab extending posteriorly from the body. Each of the first taband the second tab may have a customized patient-specific negativecontour configured to receive a respective portion of the distal end ofthe patient's femur that has a corresponding positive contour, and thefirst tab and the second tab defining an opening therebetween. In someembodiments, the customized patient-specific femoral cutting block mayinclude a first lip extending superiorly from an end of the first taband a second lip extending superiorly from an end of the second tab,each of the first tab and the second tab having a customizedpatient-specific negative contour configured to receive a respectiveportion of the posterior side of the patient's femur that has acorresponding positive contour.

In some embodiments, the first tab may extend posteriorly from the bodya first distance and the second tab may extend posteriorly form the bodya second distance, the first and second distances being substantiallydifferent. In some embodiments, the body of the customizedpatient-specific femoral cutting block may define a vertical plane andthe first tab and second tab may extend obliquely from the body withrespect to the vertical plane. Additionally, in some embodiments, thebody of the customized patient-specific femoral cutting block mayinclude a cutting slot defined therein, the cutting slot beingpositioned to allow a surgeon to perform a distal cut on the patient'sfemur using the cutting slot.

In some embodiments, the customized patient-specific femoral cuttingblock may include a cutting guide coupled to the body, the cutting guidehaving a cutting slot defined therein, the cutting guide being formedfrom a material different from the body and being positioned to allow asurgeon to perform a distal cut on the patient's femur using the cuttingslot. In some embodiments, the cutting guide may be formed from ametallic material and overmolded to the body of the customizedpatient-specific femoral cutting block.

In some embodiments, the customized patient-specific femoral cuttingblock may include a plurality of anterior guide pin bushings coupled tothe body, each of the anterior guide pin bushings being formed from amaterial different from the body and having a passageway definedtherethrough sized to receive a corresponding guide pin. In someembodiments, the body of the customized patient-specific femoral cuttingblock may include a plurality of passageways extending therethrough,each of the plurality of anterior guide pin bushings being received in acorresponding passageway of the plurality of passageways and positionedsuch that a bone-facing end of each anterior guide pin bushing isrecessed with respect to the bone-facing surface of the body.

In some embodiments, one of the plurality of passageways may be obliquewith respect to the other plurality of passageways. In some of theembodiments, each of the passageways of the body of the customizedpatient-specific femoral cutting block may be counterbored on thebone-facing surface. In some embodiments, the customizedpatient-specific femoral cutting block may include a distal guide pinbushing coupled to the at least one tab, the distal guide pin bushingbeing formed from a material different from the at least one tab andhaving a passageway defined therethrough sized to receive acorresponding guide pin. In some embodiments, the body of the customizedpatient-specific femoral cutting block may include an opening definedtherein, the opening extending superiorly from the cutting guide to apoint on the body that is more superior than the superior-most point ofeach of the plurality of anterior guide pin bushings.

In some embodiments, the at least one tab may include a groove extendinglaterally across the bone-facing side of the at least one tab, thegroove and the cutting guide defining a transverse plane. In someembodiments, the customized patient-specific femoral cutting block mayinclude a post extending anteriorly from the body, the post including apassageway defined therein, the passageway extending through the post tothe bone-facing surface of the body and being sized to receive acorresponding guide pin. In some embodiments, the body of the customizedpatient-specific femoral cutting block may include an outer surfaceopposite the bone-facing surface, the outer surface including a recessedarea. In some embodiments, the customized patient-specific femoralcutting block may include an arcuate bracket extending from the body,the arcuate bracket including a posterior bone-facing surface having anegative contour configured to receive a portion of the posterior sideof the patient's femur that has a corresponding positive contour.Additionally, in some embodiments, the body of the customizedpatient-specific femoral cutting block may include an outer surfaceopposite the bone-facing surface. The outer surface may include arecessed area sized to receive an end of a surgeon's finger. Therecessed area may correspond to a location on the body at which pressureis to be applied to couple the customized patient-specific femoralcutting block to the patient's femur.

According to another aspect, the customized patient-specific orthopaedicinstrument may include a customized patient-specific tibial cuttingblock that may include a body having a bone-facing surface having acustomized patient-specific negative contour configured to receive aportion of an anterior side of a patient's tibia that has acorresponding contour and a portion of a medial side of the patient'stibia that has a corresponding contour such that an angle greater thanzero is defined between a vertically-extending, bisecting plane of thebody and a bisecting saggital plane of the patient's tibia when theportions of the patient's tibia are received in the customizedpatient-specific negative contour of the body. The body may also includeat least one tab extending posteriorly from the body, the at least onetab having a bone-facing surface having a customized patient-specificnegative contour configured to receive a portion of the proximal side ofthe patient's tibia that has a corresponding contour.

In some embodiments, the customized patient-specific tibial cuttingblock may include a first tab extending posteriorly from the body and asecond tab extending posteriorly from the body, each of the first taband the second tab having a bone-facing surface having a customizedpatient-specific negative contour configured to receive a respectiveportion of the proximal end of the patient's tibia that has acorresponding contour, the first tab and the second tab defining anopening therebetween. In some embodiments, each of the first tab andsecond tab may include an enclosed elongated opening defined therein.

In some embodiments, the body of the customized patient-specific tibialcutting bock may include a superior end and an outer surface oppositethe bone-facing surface of the body. The superior end may include anotch defined therein and the notch extending from the outer surface tothe bone-facing surface of the body. In some embodiments, the first tabmay extend posteriorly from the body a first distance and the second tabmay extend posteriorly form the body a second distance, the first andsecond distances being substantially different.

In some embodiments, the body of the customized patient-specific tibialcutting block may define a vertical plane and the first tab and secondtab extend obliquely from the body with respect to the vertical plane.In some embodiments, the first tab may have a maximum thickness and thesecond tab may have a maximum thickness, the maximum thickness of thefirst tab being greater than the maximum thickness of the second tab. Insome embodiments, the body of the customized patient-specific tibialcutting block may include a cutting slot defined therein, the cuttingslot being positioned to allow a surgeon to perform a proximal cut onthe patient's femur using the cutting slot.

In some embodiments, the customized patient-specific tibial cuttingblock may include a cutting guide coupled to the body, the cutting guidehaving a cutting slot defined therein, the cutting guide being formedfrom a material different from the body and being positioned to allow asurgeon to perform a distal cut on the patient's femur using the cuttingslot. In some embodiments, the cutting guide may be formed from ametallic material and overmolded to the body of the customizedpatient-specific tibial cutting block. In some embodiments, thecustomized patient-specific tibial cutting block may include an outersurface opposite the bone-facing surface and a ledge extending outwardlyfrom the outer surface, the ledge having a top surface coplanar with abottom surface of the cutting slot of the cutting guide.

In some embodiments, the customized patient-specific tibial cuttingblock may include a plurality of anterior guide pin bushings coupled tothe body, each of the anterior guide pin bushings being formed from amaterial different from the body and having a passageway definedtherethrough sized to receive a corresponding guide pin. In someembodiments, the body of the customized patient-specific tibial cuttingblock includes a plurality of passageways extending therethrough, eachof the plurality of anterior guide pin bushings being received in acorresponding passageway of the plurality of passageways and positionedsuch that a bone-facing end of each anterior guide pin bushing isrecessed with respect to the bone-facing surface of the body. In someembodiments, one of the plurality of passageways may be oblique withrespect to the other plurality of passageways.

In some embodiments, each of the passageways of the body of thecustomized patient-specific tibial cutting block may be counterbored onthe bone-facing surface. Additionally, in some embodiments, thecustomized patient-specific tibial cutting block may include a proximalguide pin bushing coupled to the at least one tab, the proximal guidepin bushing being formed from a material different from the at least onetab and having a passageway defined therethrough sized to receive acorresponding guide pin. In some embodiments, the body of the customizedpatient-specific tibial cutting block may include an outer surfaceopposite the bone-facing surface, the outer surface including a recessedarea.

In some embodiments, the angle defined between the vertically-extending,bisecting plane of the body and the bisecting sagittal plane of thepatient's tibia may be between ten degrees and thirty degrees.Additionally, in some embodiments, the angle defined between thevertically-extending, bisecting plane of the body and the bisectingsagittal plane of the patient's tibia may be about twenty degrees. Insome embodiments, the tab may have a decreasing thickness in theanterior-to-posterior direction. In some embodiment, the at least onetab has a top surface that may have a concave cross-section in thesagittal plane. In some embodiments, a portion of the customizedpatient-specific negative contour of the bone-facing surface of the bodysubstantially may define a compound angle. In some embodiments, thebone-facing surface of the at least one tab may include a central recessto define a rim therearound, the customized patient-specific negativecontour of the bone facing surface of the at least one tab being definedon the rim.

According to another aspect, a customized patient-specific orthopaedicinstrument is disclosed. A customized patient-specific orthopaedicinstrument is a customized patient-specific cutting block. Thecustomized patient-specific cutting block may have a bone-facing surfaceincluding a negative contour configured to receive a portion of apatient's bone having a corresponding contour, the negative contourbeing scaled with respect to the contour of the patient's bone by apredetermined amount based on the thickness of the cartilage present onthe patient's bone.

According to one aspect, a customized patient-specific orthopaedicinstrument is disclosed. The customized patient-specific orthopaedicinstrument includes a customized patient-specific cutting block. Thecustomized patient-specific cutting block may include an anterior bodypiece, an end body piece that is separate from the anterior body piece,and a number of fasteners securing the anterior body piece and the endbody piece to one another. In some embodiments, the customizedpatient-specific cutting block may be a customized patient-specificfemoral cutting block. Additionally, in some embodiments, the customizedpatient-specific cutting block may be a customized patient-specifictibial cutting block.

The anterior body piece may include a bone-facing surface, an outersurface opposite the bone-facing surface, and a cutting guide. Thebone-facing surface may have a customized patient-specific negativecontour configured to receive a portion of an anterior side of a bone ofa patient that has a corresponding contour. In some embodiments, theanterior body piece of the customized patient-specific cutting blockfurther may include a pair of guide pin holes that extend from the outersurface to the bone-facing surface. In some embodiments, the cuttingguide of the anterior body piece may be a captured cutting guide.

The end body piece may include a bone-facing surface and an outersurface opposite the bone-facing surface. The bone-facing surface mayhave a customized patient-specific negative contour configured toreceive a portion of the bone of the patient that has a correspondingcontour. In some embodiments, the end body piece may include a pair ofguide pin holes defined therein that extend from the outer surface tothe bone-facing surface.

In some embodiments, the number of fasteners includes a number of pins.The anterior body piece and the end body piece may each have a number ofholes. The number of pins may be positioned in the number of holesdefined in the anterior body piece and the number of holes defined inthe end body piece so as to secure the anterior body piece and the endbody piece to one another.

According to another aspect, a method of performing an orthopaedicsurgical procedure on a bone of a patient is disclosed. The method mayinclude inserting an anterior body piece of a customizedpatient-specific cutting block through an incision. The method may alsoinclude inserting an end body piece of the customized patient-specificcutting block through the incision, the end body piece being separatefrom the anterior body piece. The method may include securing theanterior body piece and the end body piece to one another subsequent tothe insertion of both pieces to create an assembled customizedpatient-specific cutting block. In some embodiments, the anterior bodypiece and the end body piece may be secured to one another with a numberof pins.

The method may include positioning the assembled customizedpatient-specific cutting block in contact with the bone of the patientand making a cut in the bone of the patient with the assembledcustomized patient-specific cutting block. In some embodiments, themethod may include positioning the assembled customized patient-specificcutting block in contact with the femur of the patient. The method mayalso include making a cut in the femur of the patient with the assembledcustomized patient-specific cutting block. Additionally, in someembodiments, the method may include positioning the assembled customizedpatient-specific cutting block in contact with the tibia of the patient.The method may also include making a cut in the tibia of the patientwith the assembled customized patient-specific cutting block. In someembodiments, the method may also include inserting a pair of guide pinsinto a pair of guide pin holes defined in the assembled customizedpatient-specific cutting block prior to making the cut in the bone ofthe patient.

According to another aspect, a customized patient-specific orthopaedicinstrument is disclosed. The customized patient-specific orthopaedicinstrument may have a customized patient-specific cutting block thatincludes a body. In some embodiments, the customized patient-specificcutting block may be a customized patient-specific femoral cuttingblock. Additionally, in some embodiments, the customizedpatient-specific cutting block may be a customized patient-specifictibial cutting block.

The body may have a bone-facing surface, an outer surface opposite thebone-facing surface, and a non-captured cutting guide. The bone-facingsurface may have a customized patient-specific negative contourconfigured to receive a portion of an anterior side of a bone of apatient that has a corresponding contour. In some embodiments, the bodyof the customized patient-specific cutting block may have a pair ofguide pin holes defined therein that extend from the outer surface tothe bone-facing surface. The non-captured cutting guide may be definedby a sidewall extending from the outer surface to the bone-facingsurface.

According to one aspect, a customized patient-specific orthopaedicinstrument is disclosed. The customized patient-specific orthopaedicinstrument may include a cutting block that has an anterior bone-facingsurface and a distal bone-facing surface.

The anterior bone-facing surface may be configured to receive a portionof an anterior side of a bone of a patient. The anterior bone-facingsurface may include a first flat surface that extends distally in adirection away from the proximal-most edge of the bone cutting block andtoward the distal bone-facing surface of the cutting block. The anteriorbone-facing surface may include an anterior customized patient-specificnegative contour surface that extends distally away from the first flatsurface, the anterior customized patient-specific negative contoursurface being configured to receive the portion of the anterior side ofthe bone of the patient that has a corresponding contour. The anteriorbone-facing surface may also include a second flat surface that extendsdistally from the anterior customized patient-specific negative contoursurface toward the distal bone-facing surface

The distal bone-facing surface may be configured to receive a portion ofa distal side of the bone of the patient. The distal bone-facing surfacemay include a first flat surface that extends posteriorly in a directionaway from the anterior bone-facing surface of the bone cutting block andtoward the posterior-most edge of the cutting block. The distalbone-facing surface may include a distal customized patient-specificnegative contour surface that extends posteriorly away from the firstflat surface, the distal customized patient-specific negative contoursurface being configured to receive the portion of the distal side ofthe bone of the patient that has a corresponding contour. The distalbone-facing surface may also include a second flat surface that extendsposteriorly from the distal customized patient-specific negative contoursurface toward the posterior-most edge of the cutting block.

In some embodiments, the cutting block may be generally L-shaped and mayhave an anterior plate and a distal plate secured to, and extending awayfrom, the anterior plate. The anterior bone-facing surface may bedefined in the anterior plate and the distal bone-facing surface may bedefined in the distal place.

In some embodiments, the anterior plate may have a distal cutting guideextending through the anterior plate. Additionally, in some embodiments,the distal plate may have both an anterior cutting guide and a posteriorcutting guide extending through the distal plate. In some embodiments,the distal plate may have a pair of angled cutting guides extendingthrough the distal plate. In some embodiments, the distal plate may havean anterior cutting guide extending through the distal plate. In someembodiments, the distal plate may have a posterior cutting guideextending through the distal plate.

In some embodiments, the first flat surface of the anterior bone-facingsurface may transition to the anterior customized patient-specificnegative contour surface. The anterior customized patient-specificnegative contour surface may transition to the second flat surface ofthe anterior bone-facing surface. Additionally, in some embodiments, thefirst flat surface of the distal bone-facing surface may transition tothe distal customized patient-specific negative contour surface. Thedistal customized patient-specific negative contour surface maytransition to the second flat surface of the distal bone-facing surface.

According to another aspect, a method of performing an orthopaedicsurgical procedure on a bone of a patient is disclosed. The method mayinclude securing a customized patient-specific cutting block to the boneof the patient such that an anterior side of the bone of the patient isreceived into an anterior customized patient-specific negative contoursurface of the cutting block and a distal side of the bone of thepatient is received into a distal customized patient-specific negativecontour surface of the cutting block. The method may include making ananterior cut in the bone of the patient with the cutting block such thata flat surface is formed on the anterior side of the bone of the patientand making a distal cut in the bone of the patient with the cuttingblock such that a flat surface is formed on the distal side of the boneof the patient. The method may also include determining an amount ofadditional bone to be removed from the bone of the patient subsequent tomaking the anterior cut and the distal cut in the bone of the patient.

The method may include securing the customized patient-specific cuttingblock to the bone of the patient such that the flat surface formed inthe anterior side of the bone of the patient is positioned against atleast one flat surface formed in an anterior bone-facing surface thecutting block and the flat surface formed in the distal side of the boneof the patient is positioned against at least one flat surface formed ina distal bone-facing surface the cutting block. The method may furtherinclude making at least one of an additional anterior cut in the bone ofthe patient with the cutting block such that additional bone is removedfrom the flat surface formed on the anterior side of the bone of thepatient and an additional distal cut in the bone of the patient with thecutting block such that additional bone is removed from the flat surfaceformed on the distal side of the bone of the patient.

In some embodiments, the method may include securing the customizedpatient-specific cutting block to a femur of the patient such that ananterior side of the femur of the patient is received into the anteriorcustomized patient-specific negative contour surface of the cuttingblock and a distal side of the femur of the patient is received into thedistal customized patient-specific negative contour surface of thecutting block. In some embodiments, the method may include making bothan additional anterior cut in the bone of the patient with the cuttingblock such that additional bone is removed from the flat surface formedon the anterior side of the bone of the patient and an additional distalcut in the bone of the patient with the cutting block such thatadditional bone is removed from the flat surface formed on the distalside of the bone of the patient.

According to another aspect, a customized patient-specific orthopaedicinstrument is disclosed. The customized patient-specific orthopaedicinstrument may include a cutting block having an anterior customizedpatient-specific negative contour surface that is configured to receivea portion of the anterior side of the bone of the patient that has acorresponding contour. The cutting block may have a distal customizedpatient-specific negative contour surface that is configured to receivea portion of the distal side of the bone of the patient that has acorresponding contour. The cutting block may also have a posteriorcustomized patient-specific negative contour surface that is configuredto receive a portion of the posterior side of the bone of the patientthat has a corresponding contour.

In some embodiments, the cutting block may be generally U-shaped andhave an anterior plate, a distal plate, and a posterior plate. Theanterior bone-facing surface may be defined in the anterior plate, thedistal bone-facing surface may be defined in the distal plate, and theposterior bone-facing surface is defined in the posterior plate.

In some embodiments, the anterior plate may have a distal cutting guideextending through the anterior plate. Additionally, in some embodiments,the distal plate may have both an anterior cutting guide and a posteriorcutting guide extending through the distal plate. In some embodiments,the distal plate may have a pair of angled cutting guides extendingthrough the distal plate. In some embodiments, the distal plate may havean anterior cutting guide extending through the distal plate. In someembodiments, the distal plate may have a posterior cutting guideextending through the distal plate.

According to one aspect, an orthopaedic instrument assembly isdisclosed. The orthopaedic instrument assembly may include a customizedpatient-specific femoral cutting block, a customized patient-specifictibial cutting block, and a mechanical linkage positioned between thecustomized patient-specific femoral cutting block and the customizedpatient-specific tibial cutting block. The customized patient-specificfemoral cutting block may include a customized patient-specific negativecontour surface that is configured to receive a portion of a distalfemur of a patient that has a corresponding contour and a cutting guide.The customized patient-specific tibial cutting block may include acustomized patient-specific negative contour surface that is configuredto receive a portion of a proximal tibia of a patient that has acorresponding contour and a cutting guide. The mechanical linkage may beoperable to move the customized patient-specific femoral cutting blockand the customized patient-specific tibial cutting block away from andtoward one another.

In some embodiments, the mechanical linkage may include a number ofthreaded shafts. The rotation of the threaded shafts in a firstdirection may cause the customized patient-specific femoral cuttingblock and the customized patient-specific tibial cutting block to bemoved away from one another. The rotation of the threaded shafts in asecond, opposite direction may cause the customized patient-specificfemoral cutting block and the customized patient-specific tibial cuttingblock to be moved toward one another.

In some embodiments, the mechanical linkage may include a number ofthumbscrews coupled to the number of threaded shafts. The rotation ofthe thumbscrews in the first direction may cause rotation of thethreaded shafts in the first direction. The rotation of the thumbscrewsin the second direction may cause rotation of the threaded shafts in thesecond direction.

In some embodiments, the mechanical linkage may include a number ofthumbscrews. The rotation of the thumbscrews in a first direction maycause the customized patient-specific femoral cutting block and thecustomized patient-specific tibial cutting block to be moved away fromone another. The rotation of the thumbscrews in a second, oppositedirection may cause the customized patient-specific femoral cuttingblock and the customized patient-specific tibial cutting block to bemoved toward one another.

In some embodiments, both the customized patient-specific femoralcutting block and the customized patient-specific tibial cutting blockhave a number of guide pin holes. In some embodiments, the cutting guideof the customized patient-specific femoral cutting block issubstantially parallel to the cutting guide of the customizedpatient-specific tibial cutting block.

According to another aspect, the orthopaedic instrument assembly mayinclude a customized patient-specific femoral cutting block and aligament balancer secured to the femoral cutting block. The customizedpatient-specific femoral cutting block may have a customizedpatient-specific negative contour surface that is configured to receivea portion of a distal femur of a patient that has a correspondingcontour and a cutting guide. The ligament balancer may have a tibialbase plate and a pair of femoral paddles each of which is movablerelative to the tibial base plate.

In some embodiments, the orthopaedic instrument assembly may include abracket having a first end secured to the femoral cutting block and asecond end secured to the ligament balancer. Additionally, in someembodiments, the second end of the bracket may be secured to the tibialbase plate of the ligament balancer. In some embodiments, the first endof the bracket may have a pair of guide pin holes defined therein. Insome embodiments, the bracket may have a first end secured to thefemoral cutting block and a second end secured to the ligament balancer.The bracket may also have a receiver configured to receive anintramedullary rod.

In some embodiments, the customized patient-specific femoral cuttingblock may include a customized patient-specific anterior bone-facingsurface configured to receive a portion of an anterior side of a femurof a patient and a customized patient-specific distal bone-facingsurface configured to receive a portion of a distal side of the femur ofthe patient. In some embodiments, the ligament balancer has a pair ofcylinders secured to the tibial base plate and each of the pair offemoral paddles is received into a respective one of the pair ofcylinders.

According to another aspect, a method of an orthopaedic surgicalprocedure on a patient is disclosed. The method may include securing acustomized patient-specific femoral cutting block to the femur of thepatient and securing a ligament balancer to the tibia of the patient.The method may include securing the ligament balancer to the customizedpatient-specific femoral cutting block. The method may also includeoperating the ligament balancer to position the femur of the patient ina desired position relative to the tibia. The method may further includemaking a cut in the femur of the patient with the customizedpatient-specific cutting block.

In some embodiments, the securing of the customized patient-specificfemoral cutting block may include positioning the customizedpatient-specific femoral cutting block in contact with the femur of thepatient. The method may also include inserting at least one guide pininto at least one guide pin hole defined in the customizedpatient-specific femoral cutting block so as to secure the customizedpatient-specific femoral cutting block to the femur of the patient.

In some embodiments, the method may include the ligament balancer havinga first end of a bracket secured thereto. The second end of the bracketmay have at least one guide pin hole defined therein. The method mayalso include advancing the at least one guide pin into the at least oneguide pin hole of the bracket so as to secure the second end of thebracket to the customized patient-specific femoral cutting block. Insome embodiments, the method the ligament balancer having a first end ofa bracket secured thereto and securing a second end of the bracket tothe customized patient-specific femoral cutting block. Additionally, insome embodiments, the method may include independently moving each of apair of femoral paddles of the ligament balancer.

According to one aspect, an orthopaedic instrument assembly isdisclosed. The orthopaedic instrument assembly includes a femoralcutting block and a tibial cutting block. The femoral cutting block mayinclude a negative contour surface that is configured to receive aportion of a distal femur of a patient, a cutting guide, and a pair oftrial condylar surfaces formed in the distal end of the femoral cuttingblock. In some embodiments, the negative contour surface of the femoralcutting block may include a customized patient-specific negative contoursurface that is configured to receive a portion of a distal femur of apatient that has a corresponding contour. In some embodiments, the pairof trial condylar surfaces formed in the distal end of the femoralcutting block may include a medial condylar surface having a concaveouter profile which resembles a natural medial condyle of a femur and alateral condylar surface having a concave outer profile which resemblesa natural lateral condyle of the femur.

The tibial cutting block may have a negative contour surface that isconfigured to receive a portion of a proximal tibia of the patient, acutting guide, and a pair of trial articular surfaces formed in theproximal end of the tibial cutting block, the pair of trial articularsurfaces being configured to receive the pair of trial condylar surfacesformed in the distal end of the femoral cutting block. In someembodiments, the negative contour surface of the tibial cutting blockmay include a customized patient-specific negative contour surface thatis configured to receive a portion of a proximal tibia of a patient thathas a corresponding contour. In some embodiments, the pair of trialarticular surfaces formed in the proximal end of the tibial cuttingblock may include a medial articular surface having a convex outerprofile which resembles a natural articular surface of a medial condyleof a tibia and a lateral articular surface having a convex outer profilewhich resembles a natural articular surface of a lateral condyle of atibia.

In some embodiments, both the femoral cutting block and the tibialcutting block may have a number of guide pin holes defined therein. Insome embodiments, the cutting guide of the femoral cutting block may besubstantially parallel to the cutting guide of the tibial cutting block.

According to another aspect, a customized patient-specific orthopaedicinstrument is disclosed. The customized patient-specific orthopaedicinstrument may include a customized patient-specific cutting blockhaving a body having a femoral-facing surface having a customizedpatient-specific negative contour configured to receive a portion of afemur of a patient that has a corresponding contour. The customizedpatient-specific cutting block may also have a tibial-facing surfacehaving a customized patient-specific negative contour configured toreceive a portion of a tibia of the patient that has a correspondingcontour. The customized patient-specific cutting block may further havean outer surface opposite the femoral-facing surface and thetibial-facing surface and at least one cutting guide.

In some embodiments, the body of the customized patient-specific cuttingblock may have a tibial guide pin hole extending through the body fromthe outer surface to the tibial-facing surface. Additionally, in someembodiments, the at least one cutting guide may include a tibial cuttingguide extending through the body from the outer surface to thetibial-facing surface.

In some embodiments, the body of the customized patient-specific cuttingblock further may have a femoral guide pin hole extending through thebody from the outer surface to the femoral-facing surface. Additionally,in some embodiments, the at least one cutting guide may include afemoral cutting guide extending through the body from the outer surfaceto the femoral-facing surface.

In some embodiments, the body of the customized patient-specific cuttingblock may include an elongated tongue positioned between thefemoral-facing surface and the tibial-facing surface and extending in ageneral direction away from the outer surface. In some embodiments, thebody of the customized patient-specific cutting block may define amonolithic body.

According to another aspect, a method of performing an orthopaedicsurgical procedure on a knee of a patient may include securing acustomized patient-specific cutting block to the knee of the patientsuch that a portion of a femur of the patient is received into afemoral-facing surface having a customized patient-specific negativecontour and a portion of a tibia of the patient is received into atibial-facing surface having a customized patient-specific negativecontour. The method may also include making a cut in at least one of thetibia of the patient and the femur of the patient with the customizedpatient-specific cutting block. In some embodiments, the method mayinclude making a cut in the femur of the patient with the customizedpatient-specific cutting block. In some embodiments, the method mayinclude making a cut in the tibia of the patient with the customizedpatient-specific cutting block.

In some embodiments, the method may include inserting a guide pinthrough a tibial guide pin hole and into the tibia of the patient. Insome embodiments, the method may include inserting a guide pin through afemoral guide pin hole and into the femur of the patient.

According to one aspect, a customized patient-specific orthopaedicinstrument is disclosed. The customized patient-specific orthopaedicinstrument may include a customized patient-specific cutting blockhaving a body. In some embodiments, the customized patient-specificcutting block may be a customized patient-specific femoral cuttingblock. Additionally, in some embodiments, the customizedpatient-specific cutting block may be a customized patient-specifictibial cutting block.

The body may include a bone-facing surface having a customizedpatient-specific negative contour configured to receive a portion of abone of a patient that has a corresponding contour and an outer surfaceopposite the bone-facing surface. The body may also include a firstcutting guide corresponding to a predetermined customizedpatient-specific cutting plane and a second cutting guide that isparallel to the first cutting guide and spaced apart from the firstcutting guide by a predetermined distance. In some embodiments, the bodyof the customized patient-specific cutting block may have at least oneguide pin hole defined therein that extends from the outer surface tothe bone-facing surface.

In some embodiments, the second cutting guide may be usable to remove agreater amount of the bone of the patient relative to the first cuttingguide when the customized patient-specific cutting block is secured tothe bone of the patient. In some embodiments, the customizedpatient-specific orthopaedic instrument may include a breakaway tabcovering the second cutting guide. In some embodiments, the breakawaytab may be transparent.

In some embodiments, the body of the customized patient-specific cuttingblock may include a third cutting guide. The third cutting may beparallel to the first cutting guide and spaced apart from the firstcutting guide by the predetermined distance, and the first cutting guidemay be positioned between the second cutting guide and the third cuttingguide. In some embodiments, the third cutting guide may be usable toremove a lesser amount of the bone of the patient relative to the firstcutting guide when the customized patient-specific cutting block issecured to the bone of the patient. In some embodiments, a firsttransparent breakaway tab may cover the second cutting guide. In someembodiments, a second transparent breakaway tab may cover the thirdcutting guide.

According to another aspect, the customized patient-specific orthopaedicinstrument may include a customized patient-specific cutting block and aplurality of insert blocks each of which is configured to be receivedinto the aperture of the customized patient-specific cutting block. Thecustomized patient-specific cutting block may have a body that includesa bone-facing surface having a customized patient-specific negativecontour configured to receive a portion of a bone of a patient that hasa corresponding contour and an outer surface opposite the bone-facingsurface. An aperture may extend through the body.

Each of the plurality of insert blocks may have a cutting guide definedtherein. In some embodiments, a first insert block of the plurality ofinsert blocks may include a first cutting guide corresponding to apredetermined customized patient-specific cutting plane when the firstinsert block is positioned in the aperture of the customizedpatient-specific cutting block. A second insert block of the pluralityof insert blocks may include a second cutting guide. When the secondinsert block is positioned in the aperture of the customizedpatient-specific cutting block, the second cutting guide may be arrangedin a parallel relationship relative to the orientation in which thefirst cutting guide is arranged when the first insert block ispositioned in the aperture of the customized patient-specific cuttingblock and positioned in a position that is spaced apart by a firstpredetermined distance from the position in which the first cuttingguide is positioned when the first insert block is positioned in theaperture of the customized patient-specific cutting block. In someembodiments, the second cutting guide may be usable to remove a greateramount of the bone of the patient relative to the first cutting guide.

In some embodiments, a third insert block of the plurality of insertblocks includes a third cutting guide. When the third insert block ispositioned in the aperture of the customized patient-specific cuttingblock, the third cutting guide is arranged in a parallel relationshiprelative to the orientation in which the first cutting guide is arrangedwhen the first insert block is positioned in the aperture of thecustomized patient-specific cutting block and positioned in a positionthat is spaced apart by a second predetermined distance from theposition in which the first cutting guide is positioned when the firstinsert block is positioned in the aperture of the customizedpatient-specific cutting block, the second predetermined distance beinggreater than the first predetermined distance.

In some embodiments, a first insert block of the plurality of insertblocks may be rectangular in shape and may include a first cutting guidewhich extends through the center of the first insert block in thedirection of the long axis of the first insert block. A second insertblock of the plurality of insert blocks may be rectangular in shape andmay include a second cutting guide which extends in the direction of thelong axis of the second insert block at a positioned that is spacedapart from the center of the second insert block.

In some embodiments, the body of the customized patient-specific cuttingblock may have at least one guide pin hole defined therein that extendsfrom the outer surface to the bone-facing surface. In some embodiments,the customized patient-specific cutting block may be a customizedpatient-specific femoral cutting block. Additionally, in someembodiments, the customized patient-specific cutting block may be acustomized patient-specific tibial cutting block.

Further, in some embodiments, a first block of the plurality of insertblocks may include a first cutting guide. The first block may bepositionable in the aperture in a first orientation and a secondorientation. The first cutting guide may be offset from a longitudinalaxis of the first block such the first cutting guide defines a firstcutting plane when in the first orientation and a second cutting planewithin the second orientation. The first cutting guide may be usable bya surgeon when in the first orientation to remove a greater amount ofthe bone of the patient relative to the first cutting guide when in thesecond orientation.

According to another aspect, a customized patient-specific orthopaedicinstrument may comprise a customized patient-specific cutting blockhaving a body. The body may include a bone-facing surface having acustomized patient-specific negative contour configured to receive aportion of a bone of a patient that has a corresponding positivecontour, an outer surface opposite the bone-facing surface, an apertureextending through the body, and an adjustable cutting guide positionedin the aperture. The adjustable cutting guide may correspond to acutting plane of the bone of the patient and may be movable within theaperture to modify the position of the cutting plane. IN someembodiments, the body may include a thumbwheel coupled to the adjustablecutting guide. In such embodiments, the thumbwheel may be operable tomove the adjustable cutting guide.

According to one aspect, a customized patient-specific cutting block isdisclosed. The customized patient-specific cutting block may include acutting block body, a plurality of guide pins, and a securing device. Insome embodiments, customized patient-specific cutting block may be acustomized patient-specific femoral cutting block. In some embodiments,the customized patient-specific cutting block may be a customizedpatient-specific tibial cutting block. The cutting block body mayinclude a bone-facing surface, an outer surface opposite the bone-facingsurface, a plurality of guide pin holes formed in the body of thecutting block, and a cutting guide extending through the cutting blockbody.

The plurality of guide pins that may be respectively positioned in oneof the plurality of guide pin holes. Each of the plurality of guide pinsmay include a bone-contacting end that extends out of the bone-facingsurface of the cutting block body and may be movable relative to thecutting block body such that the bone-contacting ends of the pluralityof guide pins collectively create a customized patient-specific negativecontour configured to receive a portion of a bone of a patient that hasa corresponding contour. The securing device may be operable to lockeach of the plurality of guide pins in a desired position so as tocreate the customized patient-specific negative contour. In someembodiments, each of the plurality of guide pins may also include anouter end that extends out of the outer surface of the cutting blockbody. In some embodiments, each of the plurality of guide pins may beindependently movable relative to each other.

According to another aspect, a customized patient-specific orthopaedicinstrument is disclosed. The customized patient-specific orthopaedicinstrument includes a customized patient-specific cutting block and anelectronic programming device. The customized patient-specific cuttingblock may have a body with a cutting guide extending therethrough and aplurality of guide pins, each of which includes a bone-contacting endthat extends out of the body of the cutting block.

Each of the plurality of guide pins may also be movable relative to thebody of the cutting block such that the bone-contacting ends of theplurality of guide pins collectively create a customizedpatient-specific negative contour configured to receive a portion of abone of a patient that has a corresponding contour. In some embodiments,the customized patient-specific cutting block may include a securingdevice operable to lock each of the plurality of guide pins in thedesired position. In some embodiments, each of the plurality of guidepins may be independently movable relative to each other.

The electronic programming device may include a housing having anaperture formed therein and one or more electrically-operated actuatorsoperable to position each of the plurality of guide pins in a desiredposition so as to create the customized patient-specific negativecontour. The aperture may be configured to receive the customizedpatient-specific cutting block therein. In some embodiments, theelectronic programming device further may include a coupler configuredto operate the securing device of the customized patient-specificcutting block.

In some embodiments, the electronic programming device may include aplurality of holes each of which is configured to receive one of theplurality of guide pins of the customized patient-specific cuttingblock. One of a plurality of push rods may be located in each of theholes. One or more electrically-operated actuators may be operable toposition the plurality of push rods in a respective position so as toposition each of the plurality of guide pins in the desired position.

In some embodiments, the electronic programming device may also includea processor and a memory device electrically coupled to the processor.The memory device may have stored therein a plurality of instructionswhich, when executed by the processor, cause the processor to operatethe one or more electrically-operated actuators to position each of theplurality of guide pins in the desired position. In some embodiments,the electronic programming device may include an input port electricallycoupled to the memory device.

In some embodiments, each of the plurality of guide pins may beindependently movable relative to each other. In some embodiments,customized patient-specific cutting block may be a customizedpatient-specific femoral cutting block. In some embodiments, thecustomized patient-specific cutting block may be a customizedpatient-specific tibial cutting block.

According to one aspect, a method for a vendor to create a customizedpatient-specific orthopaedic instrument for a patient of a healthcarefacility that is external to the vendor is disclosed. The method mayinclude receiving an instrument request that includes data relevant tothe patient from the healthcare facility external to the vendor. In someembodiments, the data of the instrument request may include one or moremedical images that depict at least one bone of the patient. Receivingmay include receiving the instrument request that includes the one ormore medical images.

The method may also include creating a design plan that has beencustomized for the patient per data of the instrument request inresponse to receiving the instrument request. In some embodiments, thedesign plan may be created based upon one or more medical images thatdepict at least one bone of the patient. The method may include sendingthe design plan to the healthcare facility. Sending may includetransmitting the design plan to the healthcare facility via a network.Second may also include mailing the design plan to the healthcarefacility.

The method may further include operating a milling machine located atthe healthcare facility to fabricate the customized patient-specificorthopaedic instrument per data of the design plan. In some embodiments,the method may include generating a plurality of instructions for thedesign plan that are executed by a processor of the milling machine tofabricate the customized patient-specific orthopaedic instrument. Insome embodiments, the method may include generating the plurality ofinstructions based upon one or more medical images that depict at leastone bone of the patient.

In some embodiments, operating may include operating the milling machinelocated at the healthcare facility to fabricate a customizedpatient-specific cutting block per data of the design plan. In someembodiments, operating may include operating the milling machine locatedat the healthcare facility to fabricate a customized patient-specificfemoral cutting block per data of the design plan. Additionally, in someembodiments, operating may include operating the milling machine locatedat the healthcare facility to fabricate a customized patient-specifictibial cutting block per data of the design plan.

According to another aspect, a system for creating a customizedpatient-specific orthopaedic instrument for a patient of a healthcarefacility is disclosed. The system may include a client to generate aninstrument request that includes data relevant to the patient, a designplan system to receive the instrument request and to generate a designplan that has been customized based upon the data of the instrumentrequest, the design plan system being located at a vendor, and a millingmachine located at the healthcare facility which is external to thevendor, the milling machine being operable to fabricate the customizedpatient-specific orthopaedic instrument per data of the design plangenerated by the design plan system.

In some embodiments, the design plan system may generate the design planbased upon at least one image of the instrument request. In someembodiments, the client may be communicatively coupled to the designplan system via a network. In some embodiments, the design plan systemmay be communicatively coupled to the milling machine via a network. Insome embodiments, the client may be communicatively coupled to thedesign plan system via a network.

In some embodiments, the milling machine may be operable to fabricate acustomized patient-specific cutting block per data of the design plangenerated by the design plan system. In some embodiments, the millingmachine may be operable to fabricate a customized patient-specificfemoral cutting block per data of the design plan generated by thedesign plan system. In some embodiments, the milling machine may beoperable to fabricate a customized patient-specific tibial cutting blockper data of the design plan generated by the design plan system.

According to one aspect, a customized patient-specific orthopaedicinstrument assembly is disclosed. The customized patient-specificorthopaedic instrument assembly may include a customizedpatient-specific cutting block, an ankle brace, and an externalalignment rod. In some embodiments, the customized patient-specificcutting block may be a customized patient-specific femoral cuttingblock. In some embodiments, customized patient-specific cutting blockmay be a customized patient-specific tibial cutting block. Thecustomized patient-specific cutting block may include a bone-facingsurface having a customized patient-specific negative contour configuredto receive a portion of an anterior side of a bone of a knee of apatient that has a corresponding contour, an outer surface opposite thebone-facing surface, at least one guide pin hole, and a cutting guide.

The ankle brace may be configured to be secured externally to an ankleof the patient. In some embodiments, the ankle brace may include a rearstrap configured to wrap around the posterior side of the ankle of thepatient. The external alignment rod may have a first end secured to thecustomized patient-specific cutting block and a second end secured tothe ankle brace. In some embodiments, the alignment rod may betelescoping and may have a first rod which is received into a secondrod. In some embodiments, the alignment rod may also include a securingdevice that is operable to lock the first rod and the second rod in afixed position relative to one another.

According to another aspect, the customized patient-specific orthopaedicinstrument assembly may include a customized patient-specific cuttingblock, an alignment cord having a first end secured to the customizedpatient-specific cutting block, and a weight secured to a second end ofthe alignment cord. The customized patient-specific cutting block mayinclude a bone-facing surface having a customized patient-specificnegative contour configured to receive a portion of an anterior side ofa bone of a knee of a patient that has a corresponding contour. Thecustomized patient-specific cutting block may also include an outersurface opposite the bone-facing surface, at least one guide pin hole,and a cutting guide. In some embodiments, the customizedpatient-specific cutting block may be a customized patient-specificfemoral cutting block. In some embodiments, customized patient-specificcutting block may be a customized patient-specific tibial cutting block.

In some embodiments, the customized patient-specific cutting block mayinclude an extension rod extending anteriorly from the outer surfacethereof, and the first end of the alignment cord may be secured to theextension rod. Additionally, in some embodiments, the alignment cord mayextend inferiorly from the extension rod. In some embodiments, thealignment cord may extend inferiorly from the customizedpatient-specific cutting block.

According to another aspect, the customized patient-specific orthopaedicinstrument assembly may include a customized patient-specific cuttingblock and an external alignment device. The customized patient-specificcutting block may include a bone-facing surface having a customizedpatient-specific negative contour configured to receive a portion of ananterior side of a bone of a knee of a patient that has a correspondingcontour. The customized patient-specific cutting block may also includean outer surface opposite the bone-facing surface, at least one guidepin hole, and a cutting guide. In some embodiments, the customizedpatient-specific cutting block may be a customized patient-specificfemoral cutting block. In some embodiments, customized patient-specificcutting block may be a customized patient-specific tibial cutting block.

The external alignment device may have a first end secured to thecustomized patient-specific cutting block and second end that extendsinferiorly from the customized patient-specific cutting block. In someembodiments, the external alignment device may include an elongated rod.In some embodiments, the external alignment device may include an anklebrace configured to be secured externally to an ankle of the patient.The external alignment device may also include a first end of theelongated rod is secured to the customized patient-specific cuttingblock and a second end of the elongated rod is secured to the anklebrace. In some embodiments, the elongated rod may be a telescoping rod.

In some embodiments, the external alignment device may include analignment cord having a first end secured to the customizedpatient-specific cutting block and a weight secured to a second end ofthe alignment cord. Additionally, in some embodiments, the customizedpatient-specific cutting block may have an extension rod extendinganteriorly from the outer surface thereof and the first end of thealignment cord may be secured to the extension rod.

According to one aspect, a method for designing a customizedpatient-specific bone cutting block for use in an orthopaedic surgicalprocedure to perform a bone cut on a patient's bone is disclosed. Themethod may include determining a cartilage thickness value indicative ofthe average thickness of the cartilage present on a relevant end of thepatient's bone and determining a reference contour based on a surfacecontour of the relevant end of the patient's bone. The method may alsoinclude generating a scaled reference contour by scaling the referencecontour based on the cartilage thickness value. The method may includedefining a customized patient-specific negative contour of thecustomized patient-specific bone cutting block using the scaledreference contour.

In some embodiments, the method may include determining the cartilagethickness value based on the gender of the patient. In some embodiments,the method may include determining a reference contour based on asurface contour of a three-dimensional model of the patient's bone. Insome embodiments, the method may include determining a reference pointin the three-dimensional model of the patient's bone and increasing thedistance between the reference point and a point on the referencecontour.

In some embodiments, the method may include generating a first linesegment extending from a first point defined on the surface contour of amedial side of the three-dimensional model to a second point defined onthe surface contour of a lateral side of the three-dimensional model.The method may include generating a second line segment extending from athird point defined on the surface contour of an anterior side of thethree-dimensional model to a fourth point defined on the surface contourof a posterior side of the three-dimensional model, wherein the first,second, third, and forth points are coplanar. The method may includedetermining a point of intersection between the first line segment andthe second line segment, the point of intersection corresponding to thereference point. Determining the reference point may include moving thereference point away from the point of intersection a distanceapproximately equal to half the length of the second line segment.

In some embodiments, the method may include determining a length valueequal to a percentage of the distance between the reference point andthe point on the reference contour and increasing the distance betweenthe reference point and the point on the reference contour by the lengthvalue. In some embodiments, the method may include determining areas ofthe relevant end of the patient's bone having a reduced thickness ofcartilage and adjusting the scaled reference contour to compensate forthe areas of reduced thickness of cartilage of the relevant end of thepatient's bone. In some embodiments, determining areas of the relevantend of the patient's bone having the reduced thickness of cartilage mayinclude identifying points of bone-on-bone contact between the patient'sfemur and the patient's tibia based on a medical image of the femur andtibia.

In some embodiments, adjusting the scaled reference contour may includedecreasing the distance between the reference point and a point on thereference contour corresponding to the areas of reduced thickness ofcartilage. In some embodiments, reference contour may include ananterior side, a medial side, and a lateral side. Generating the scaledreference contour may include increasing the distance between thereference point and the anterior side and subsequently reducing thedistance between the reference point and the medial side and between thereference point and the lateral side.

In some embodiments, the method may include determining a referencecontour based on a surface contour of an osteophite of the patient'sbone. In some embodiments, the method may include generating a scaledreference contour having a superior end defining a negative contourcorresponding to a surface contour of the patient's femur locatedsuperiorly to a cartilage demarcation line of the patient's femur. Insome embodiments, the method may include generating a scaled referencecontour having an inferior end defining a negative contour correspondingto a surface contour of the patient's tibia located inferiorly to acartilage demarcation line of the patient's tibia.

In some embodiments, the method may include determining a position of acutting guide of the customized patient-specific cutting block. In someembodiments, the position of the cutting guide may be determined basedon an angle defined between a mechanical axis of the patient's femur anda mechanical axis of the patient's tibia.

According to another aspect, a method for generating a customizedpatient-specific negative contour of a customized patient-specific bonecutting block is disclosed. The method may include determining acartilage thickness value indicative of the average thickness of thecartilage present on a relevant end of a patient's bone. The method mayalso include determining a reference contour corresponding to a surfacecontour of a three-dimensional model of the relevant end of thepatient's bone. The method may include determining a reference point inthe three-dimensional model of the patient's bone and increasing thedistance between the reference point and a point on the referencecontour. The method may include defining a customized patient-specificnegative contour of the customized patient-specific bone cutting blockusing the scaled reference contour.

In some embodiments, determining the reference point may includegenerating a first line segment extending from a first point defined onthe surface contour of a medial side of the three-dimensional model to asecond point defined on the surface contour of a lateral side of thethree-dimensional model. The method may also include generating a secondline segment extending from a third point defined on the surface contourof an anterior side of the three-dimensional model to a fourth pointdefined on the surface contour of a posterior side of thethree-dimensional model, wherein the first, second, third, and forthpoints are coplanar. The method may include determining a point ofintersection between the first line segment and the second line segment,the point of intersection corresponding to the reference point.

In some embodiments, determining the reference point may include movingthe reference point away from the point of intersection a distanceapproximately equal to half the length of the second line segment. Insome embodiments, increasing the distance between the reference pointand the point on the reference contour may include determining a lengthvalue equal to a percentage of the distance between the reference pointand the point on the reference contour. In some embodiments, thepercentage may be about ten percent. Increasing the distance between thereference point and the point on the reference contour may also includeincreasing the distance between the reference point and the point on thereference contour by the length value.

In some embodiments, the method may include determining areas of therelevant end of the patient's bone having a reduced thickness ofcartilage and adjusting the scaled reference contour to compensate forthe areas of reduced thickness of cartilage of the relevant end of thepatient's bone. In some embodiments, adjusting the scaled referencecontour may include decreasing the distance between the reference pointand a point on the reference contour corresponding to the areas ofreduced thickness of cartilage.

In some embodiments, the reference contour may include an anterior side,a medial side, and a lateral side. Scaling the reference contour mayinclude increasing the distance between the reference point and theanterior side and subsequently reducing the distance between thereference point and the medial side and between the reference point andthe lateral side. In some embodiments, the method may includedetermining a reference contour based on a surface contour of anosteophite of the patient's bone.

According to another aspect, a method for fabricating a customizedpatient-specific bone cutting block is disclosed. The method may includedetermining a cartilage thickness value indicative of the averagethickness of the cartilage present on a relevant end of a patient'sbone. The method may include determining a reference contourcorresponding to a surface contour of the relevant end of athree-dimensional image of the patient's bone. The method may alsoinclude generating a scaled reference contour by scaling the referencecontour based on the cartilage thickness value. The method may includeestablishing a customized patient-specific negative contour on a bonecutting block blank based on the scaled reference contour. In someembodiments, the method may include determining areas of the relevantend of the patient's bone having a reduced thickness of cartilage andadjusting the scaled reference contour to compensate for the areas ofreduced thickness of cartilage of the relevant end of the patient'sbone.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the following figures,in which:

FIG. 1 is a simplified flow diagram of an algorithm for designing andfabricating a customized patient-specific orthopaedic surgicalinstrument;

FIG. 2 is a simplified flow diagram of a method for generating a modelof a patient-specific orthopaedic instrument;

FIG. 3 is a simplified flow diagram of a method for scaling a referencecontour;

FIGS. 4-6 are three-dimensional model's of a patient's tibia;

FIG. 7-9 are three-dimensional models of a patient's femur;

FIG. 10 is an elevation view of one embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 11 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 10;

FIG. 12 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 10 secured to a bone of apatient;

FIG. 13 is an elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 14 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 13;

FIG. 15 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 13 secured to a bone of apatient;

FIG. 16 is an elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 17 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 16;

FIG. 18 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 16 secured to a bone of apatient;

FIG. 19 is an elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 20 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 19;

FIG. 21 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 19 secured to a bone of apatient;

FIG. 22 is a perspective view of another embodiment of the customizedpatient-specific orthopaedic surgical instrument of FIG. 19 secured to abone of a patient;

FIG. 23 is an elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 24 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 23;

FIG. 25 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 23 secured to a bone of apatient;

FIG. 26 is an elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 27 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 26;

FIG. 28 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 26 secured to a bone of apatient;

FIG. 29 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 30 is an elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 29 coupled to a bone of apatient;

FIG. 31 is an exploded perspective view of another embodiment of acustomized patient-specific orthopaedic surgical instrument;

FIG. 32 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 31 in an assembled configurationand coupled to a bone of a patient

FIG. 33 is a side elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 34 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument coupled to a bone of apatient;

FIG. 35 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 36 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 35 coupled to a bone of apatient;

FIG. 37 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument coupled tothe bony anatomy of a patient;

FIG. 38 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument coupled tothe bony anatomy of a patient;

FIG. 39 is a side elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument coupled to a bone of apatient;

FIG. 40 is a side elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument coupled to a bone of apatient;

FIG. 41 is a side elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument coupled to a bone of apatient;

FIG. 42 is a side elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument coupled to the knee ofa patient in extension;

FIG. 43 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 42 with the patient's knee inflexion;

FIG. 44 is a side elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument coupled to a patient'sknee in flexion;

FIG. 45 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument coupled to a bone of apatient;

FIG. 46 is another perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 45;

FIG. 47 is a cross-sectional elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument;

FIG. 48 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument coupled to abone of a patient;

FIG. 49 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument coupled to abone of a patient;

FIG. 50 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 49;

FIG. 51 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument;

FIG. 52 is a side elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument coupled to a bone of apatient;

FIG. 53 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 54 is a perspective view of the customized patient-specificorthopaedic surgical instrument of FIG. 53 coupled to a bone of apatient;

FIG. 55 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument;

FIG. 56 is a top plan view of the customized patient-specificorthopaedic surgical instrument of FIG. 55;

FIG. 57 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 55;

FIG. 58 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument;

FIG. 59 is a top plan view of the customized patient-specificorthopaedic surgical instrument of FIG. 58;

FIG. 60 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 58;

FIG. 61 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument;

FIG. 62 is a top plan view of the customized patient-specificorthopaedic surgical instrument of FIG. 61;

FIG. 63 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 61;

FIG. 64 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument;

FIG. 65 is a top plan view of the customized patient-specificorthopaedic surgical instrument of FIG. 64;

FIG. 66 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 64;

FIG. 67 is a perspective view of one embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 68 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 67 coupled to a bone of apatient;

FIG. 69 is a side elevation view of a pair of universal bone-cuttingblocks coupled to the bone of the patient of FIG. 68;

FIG. 70 is a front elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument coupled to the bonyanatomy of a patient;

FIG. 71 is a front elevation view of a pair of re-cut bone-cuttingblocks coupled to the bony anatomy of the patient of FIG. 70;

FIG. 72 is a side elevation view of another embodiment of a re-cutbone-cutting block;

FIG. 73 is a top perspective view of another embodiment of a re-cutcutting block;

FIG. 74 is an end elevation view of the re-cut bone-cutting block ofFIG. 73;

FIG. 75 is a side elevation view of the re-cut bone-cutting block ofFIG. 73 coupled to a bone of a patient;

FIG. 76 is a side elevation view of another embodiment of the re-cutbone-cutting block of FIG. 73 coupled to a bone of a patient;

FIG. 77 is a perspective view of one embodiment of an orthopaedicsurgical instrument;

FIG. 78 is a partial side elevation view of the orthopaedic surgicalinstrument of FIG. 77;

FIG. 79 is a cross-sectional view of the orthopaedic surgical instrumentof FIG. 78;

FIG. 80 is a partial side elevation view of another embodiment of theorthopaedic surgical instrument of FIG. 78;

FIG. 81 is a perspective view of one embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 82 is an anterior elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 81 secured to a bone of apatient;

FIG. 83 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument secured to abone of a patient;

FIG. 84 is an exploded perspective view of another embodiment of acustomized patient-specific orthopaedic surgical instrument secured to abone of a patient;

FIG. 85 is an anterior elevation view of one embodiment of thecustomized patient-specific orthopaedic surgical instrument of FIG. 84secured to a bone of a patient;

FIG. 86 is an anterior elevation view of another embodiment of thecustomized patient-specific orthopaedic surgical instrument of FIG. 84secured to a bone of a patient;

FIG. 87 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument secured to abone of a patient;

FIG. 88 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument secured to a bone of apatient;

FIG. 89 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument secured to a bone of apatient;

FIG. 90 a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 91 is a perspective view of a tool for use with the customizedpatient-specific orthopaedic surgical instrument of FIG. 90;

FIG. 92 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 90;

FIG. 93 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 94 is a side elevation view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument secured to a bone of apatient;

FIG. 95 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 94 after a bone resectionprocedure;

FIG. 96 is a perspective view of one embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 97 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument secured to a leg of apatient;

FIG. 98 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument secured to a leg of apatient;

FIG. 99 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument secured to a leg of apatient;

FIG. 100 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument secured to a leg of apatient;

FIG. 101 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument secured to a leg of apatient;

FIG. 102 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument secured to a bone of apatient;

FIG. 103 is a top plan view of the customized patient-specificorthopaedic surgical instrument of FIG. 102;

FIG. 104 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 105 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument secured to abone of a patient;

FIG. 106 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 105;

FIG. 107 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 108 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 107 secured to a bone of apatient;

FIG. 109 is a perspective view of another embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 110 is a top plan view of the customized patient-specificorthopaedic surgical instrument of FIG. 109 secured to a bone of apatient;

FIG. 111 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument secured to abone of a patient;

FIG. 112 is a top elevation proximal-to-distal view of the customizedpatient-specific orthopaedic surgical instrument of FIG. 111;

FIG. 113 is a top elevation view of another embodiment of the customizedpatient-specific orthopaedic surgical instrument of FIG. 111;

FIG. 114 is a top elevation view of another embodiment of the customizedpatient-specific orthopaedic surgical instrument of FIG. 111;

FIG. 115 is a top elevation view of another embodiment of the customizedpatient-specific orthopaedic surgical instrument of FIG. 111;

FIG. 116 is an anterior elevation view of one embodiment of a leg bracefor securing a patient's leg;

FIG. 117 is an anterior elevation view of a bone of a patient having anumber of markers coupled thereto;

FIG. 118 is an anterior elevation view of another bone of a patienthaving a marking thereon;

FIG. 119 is an exploded perspective view of a customizedpatient-specific orthopaedic surgical instrument for use with a bone ofa patient;

FIG. 120 is an exploded perspective view of another customizedpatient-specific orthopaedic surgical instrument for use with a bone ofa patient;

FIG. 121 is a bottom perspective view of another embodiment of acustomized patient-specific orthopaedic surgical instrument;

FIG. 122 is a side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 121 coupled to a bone of apatient;

FIG. 123 is a perspective view of a programming device for use with thecustomized patient-specific orthopaedic surgical instrument of FIG. 121;and

FIG. 124 is a simplified block diagram of a milling machine forfabrication of customized patient-specific orthopaedic surgicalinstruments.

DETAILED DESCRIPTION OF THE DRAWINGS

While the concepts of the present disclosure are susceptible to variousmodifications and alternative forms, specific exemplary embodimentsthereof have been shown by way of example in the drawings and willherein be described in detail. It should be understood, however, thatthere is no intent to limit the concepts of the present disclosure tothe particular forms disclosed, but on the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

Referring to FIG. 1, an algorithm 10 for fabricating a customizedpatient-specific orthopaedic surgical instrument is illustrated. What ismeant herein by the term “customized patient-specific orthopaedicsurgical instrument” is a surgical tool for use by a surgeon inperforming an orthopaedic surgical procedure that is intended, andconfigured, for use on a particular patient. As such, it should beappreciated that, as used herein, the term “customized patient-specificorthopaedic surgical instrument” is distinct from standard, non-patientspecific orthopaedic surgical instruments that are intended for use on avariety of different patients. Additionally, it should be appreciatedthat, as used herein, the term “customized patient-specific orthopaedicsurgical instrument” is distinct from orthopaedic prostheses, whetherpatient-specific or generic, which are surgically implanted in the bodyof the patient. Rather, customized patient-specific orthopaedic surgicalinstruments are used by an orthopaedic surgeon to assist in theimplantation of orthopaedic prostheses.

In some embodiments, the customized patient-specific orthopaedicsurgical instrument may be customized to the particular patient based onthe location at which the instrument is to be coupled to one or morebones of the patient, such as the femur and/or tibia. For example, insome embodiments, the customized patient-specific orthopaedic surgicalinstrument may include a bone-contacting or facing surface having anegative contour that matches or substantially matches the contour of aportion of the relevant bone of the patient. As such, the customizedpatient-specific orthopaedic surgical instrument is configured to becoupled to the bone of a patient in a unique location and position withrespect to the patient's bone. That is, the negative contour of thebone-contacting surface is configured to receive the matching contoursurface of the portion of the patient's bone. As such, the orthopaedicsurgeon's guesswork and/or intra-operative decision-making with respectto the placement of the orthopaedic surgical instrument are reduced. Forexample, the orthopaedic surgeon may not be required to locate landmarksof the patient's bone to facilitate the placement of the orthopaedicsurgical instrument, which typically requires some amount of estimationon part of the surgeon. Rather, the orthopaedic surgeon may simplycouple the customized patient-specific orthopaedic surgical instrumenton the bone or bones of the patient in the unique location. When socoupled, the cutting plane, drilling holes, milling holes, and/or otherguides are defined in the proper location relative to the bone andintended orthopaedic prosthesis. The customized patient-specificorthopaedic surgical instrument may be embodied as any type oforthopaedic surgical instrument such as, for example, a bone-cuttingblock, a drilling guide, a milling guide, or other type of orthopaedicsurgical instrument configured to be coupled to a bone of a patient.

As shown in FIG. 1, the algorithm 10 includes process steps 12 and 14,in which an orthopaedic surgeon performs pre-operative planning of theorthopaedic surgical procedure to be performed on a patient. The processsteps 12 and 14 may be performed in any order or contemporaneously witheach other. In process step 12, a number of medical images of therelevant bony anatomy or joint of the patient are generated. To do so,the orthopaedic surgeon or other healthcare provider may operate animaging system to generate the medical images. The medical images may beembodied as any number and type of medical images capable of being usedto generate a three-dimensional rendered model of the patient's bonyanatomy or relevant joint. For example, the medical images may beembodied as any number of computed tomography (CT) images, magneticresonance imaging (MRI) images, or other three-dimensional medicalimages. Additionally or alternatively, as discussed in more detail belowin regard to process step 18, the medical images may be embodied as anumber of X-ray images or other two-dimensional images from which athree-dimensional rendered model of the patient's relevant bony anatomymay be generated. Additionally, in some embodiments, the medical imagemay be enhanced with a contrast agent designed to highlight thecartilage surface of the patient's knee joint.

In process step 14, the orthopaedic surgeon may determine any additionalpre-operative constraint data. The constraint data may be based on theorthopaedic surgeon's preferences, preferences of the patient,anatomical aspects of the patient, guidelines established by thehealthcare facility, or the like. For example, the constraint data mayinclude the orthopaedic surgeon's preference for a metal-on-metalinterface, amount of inclination for implantation, the thickness of thebone to resect, size range of the orthopaedic implant, and/or the like.In some embodiments, the orthopaedic surgeon's preferences are saved asa surgeon's profile, which may be used as a default constraint valuesfor further surgical plans.

In process step 16, the medical images and the constraint data, if any,are transmitted or otherwise provided to an orthopaedic surgicalinstrument vendor or manufacturer. The medical images and the constraintdata may be transmitted to the vendor via electronic means such as anetwork or the like. After the vendor has received the medical imagesand the constraint data, the vendor processes the images in step 18. Theorthopaedic surgical instrument vendor or manufacturer processes themedical images to facilitate the determination of the bone cuttingplanes, implant sizing, and fabrication of the customizedpatient-specific orthopaedic surgical instrument as discussed in moredetail below. For example, in process step 20 the vendor may convert orotherwise generate three-dimensional images from the medical images. Forexample, in embodiments wherein the medical images are embodied as anumber of two-dimensional images, the vendor may use a suitable computeralgorithm to generate one or more three-dimensional images from thenumber of two-dimensional images. Additionally, in some embodiments, themedical images may be generated based on an established standard such asthe Digital Imaging and Communications in Medicine (DICOM) standard. Insuch embodiments, an edge-detection, thresholding, watershead, orshape-matching algorithm may be used to convert or reconstruct images toa format acceptable in a computer aided design application or otherimage processing application. Further, in some embodiments, an algorithmmay be used to account for tissue such as cartilage not discernable inthe generated medical images. In such embodiments, any three-dimensionalmodel of the patient-specific instrument (see, e.g., process step 26below) may be modified according to such algorithm to increase the fitand function of the instrument.

In process step 22, the vendor may process the medical images, and/orthe converted/reconstructed images from process step 20, to determine anumber of aspects related to the bony anatomy of the patient such as theanatomical axis of the patient's bones, the mechanical axis of thepatient's bone, other axes and various landmarks, and/or other aspectsof the patient's bony anatomy. To do so, the vendor may use any suitablealgorithm to process the images.

In process step 24, the cutting planes of the patient's bone aredetermined. The planned cutting planes are determined based on the type,size, and position of the orthopaedic prosthesis to be used during theorthopaedic surgical procedure, on the process images such as specificlandmarks identified in the images, and on the constraint data suppliedby the orthopaedic surgeon in process steps 14 and 16. The type and/orsize of the orthopaedic prosthesis may be determined based on thepatient's anatomy and the constraint data. For example, the constraintdata may dictate the type, make, model, size, or other characteristic ofthe orthopaedic prosthesis. The selection of the orthopaedic prosthesismay also be modified based on the medical images such that anorthopaedic prosthesis that is usable with the bony anatomy of thepatient and that matches the constraint data or preferences of theorthopaedic surgeon is selected.

In addition to the type and size of the orthopaedic prosthesis, theplanned location and position of the orthopaedic prosthesis relative tothe patient's bony anatomy is determined. To do so, a digital templateof the selected orthopaedic prosthesis may be overlaid onto one or moreof the processed medical images. The vendor may use any suitablealgorithm to determine a recommended location and orientation of theorthopaedic prosthesis (i.e., the digital template) with respect to thepatient's bone based on the processed medical images (e.g., landmarks ofthe patient's bone defined in the images) and/or the constraint data.Additionally, any one or more other aspects of the patient's bonyanatomy may be used to determine the proper positioning of the digitaltemplate.

In some embodiments, the digital template along with surgical alignmentparameters may be presented to the orthopaedic surgeon for approval. Theapproval document may include the implant's rotation with respect tobony landmarks such as the femoral epicondyle, posterior condyles,sulcus groove (Whiteside's line), and the mechanical axis as defined bythe hip, knee, and/or ankle centers.

The planned cutting planes for the patient's bone(s) may then bedetermined based on the determined size, location, and orientation ofthe orthopaedic prosthesis. In addition, other aspects of the patient'sbony anatomy, as determined in process step 22, may be used to determineor adjust the planned cutting planes. For example, the determinedmechanical axis, landmarks, and/or other determined aspects of therelevant bones of the patient may be used to determine the plannedcutting planes.

In process step 26, a model of the customized patient-specificorthopaedic surgical instrument is generated. In some embodiments, themodel is embodied as a three-dimensional rendering of the customizedpatient-specific orthopaedic surgical instrument. In other embodiments,the model may be embodied as a mock-up or fast prototype of thecustomized patient-specific orthopaedic surgical instrument. Theparticular type of orthopaedic surgical instrument to be modeled andfabricated may be determined based on the orthopaedic surgical procedureto be performed, the constraint data, and/or the type of orthopaedicprosthesis to be implanted in the patient. As such, the customizedpatient-specific orthopaedic surgical instrument may be embodied as anytype of orthopaedic surgical instrument for use in the performance of anorthopaedic surgical procedure. For example, the orthopaedic surgicalinstrument may be embodied as a bone-cutting block, a drilling guide, amilling guide, and/or any other type of orthopaedic surgical tool orinstrument.

The particular shape of the customized patient-specific orthopaedicsurgical instrument is determined based on the planned location of theorthopaedic surgical instrument relative to the patient's bony anatomy.The location of the customized patient-specific orthopaedic surgicalinstrument with respect to the patient's bony anatomy is determinedbased on the type and determined location of the orthopaedic prosthesisto be used during the orthopaedic surgical procedure. That is, theplanned location of the customized patient-specific orthopaedic surgicalinstrument relative to the patient's bony anatomy may be selected basedon, in part, the planned cutting planes of the patient's bone(s) asdetermined in step 24. For example, in embodiments wherein thecustomized patient-specific orthopaedic surgical instrument is embodiedas a bone-cutting block, the location of the orthopaedic surgicalinstrument is selected such that the cutting guide of the bone-cuttingblock matches one or more of the planned cutting planes determined inprocess step 24. Additionally, the planned location of the orthopaedicsurgical instrument may be based on the identified landmarks of thepatient's bone identified in process step 22.

In some embodiments, the particular shape or configuration of thecustomized patient-specific orthopaedic surgical instrument may bedetermined based on the planned location of the instrument relative tothe patient's bony anatomy. That is, the customized patient-specificorthopaedic surgical instrument may include a bone-contacting surfacehaving a negative contour that matches the contour of a portion of thebony anatomy of the patient such that the orthopaedic surgicalinstrument may be coupled to the bony anatomy of the patient in a uniquelocation, which corresponds to the pre-planned location for theinstrument. When the orthopaedic surgical instrument is coupled to thepatient's bony anatomy in the unique location, one or more guides (e.g.,cutting or drilling guide) of the orthopaedic surgical instrument may bealigned to one or more of the bone cutting plane(s) as discussed above.

One illustrative embodiment of a method 40 for generating a model, suchas a computer model, of a patient-specific orthopaedic instrument isillustrated in FIGS. 2 through 9. The method 40 begins with a step 42 inwhich a cartilage thickness value is determined. The cartilage thicknessvalue is indicative of the average thickness of the cartilage of thepatient's bone. As such, in one embodiment, the cartilage thicknessvalue is equal to the average thickness of cartilage for an individualhaving similar characteristics as the patient. For example, thecartilage thickness value may be equal to the average thickness value ofindividuals of the same gender as the patient, the same age as thepatient, having the same activity level of the patient, and/or the like.In other embodiments, the cartilage thickness value is determined basedon one or more medical images of the patient's bone, such as thoseimages transmitted in process step 16.

In step 44, a reference contour of the patient's relevant bone isdetermined. The reference contour is based on the surface contour of athree-dimensional model of the patient's relevant bone, such as thethree-dimensional model generated in step 20. Initially the referencecontour is identical to a region (i.e. the region of interest such asthe distal end of the patient's femur or the proximal end of thepatient's tibia) of the patient's bone. That is, in some embodiments,the reference contour is juxtaposed on the surface contour of the regionof the patient's bone.

Subsequently, in step 46, the reference contour is scaled to compensatefor the cartilage thickness value determined in step 42. To do so, inone embodiment, the scale of the reference contour is increased based onthe cartilage thickness value. For example, the scale of the referencecontour may be increased by an amount equal to or determined from thecartilage thickness value. However, in other embodiments, the referencecontour may be scaled using other techniques designed to scale thereference contour to a size at which the reference contour iscompensated for the thickness of the cartilage on the patient's bone.

For example, in one particular embodiment, the reference contour isscaled by increasing the distance between a fixed reference point and apoint lying on, and defining in part, the reference contour. To do so,in one embodiment, a method 60 for scaling a reference contour asillustrated in FIG. 3 may be used. The method 60 begins with step 62 inwhich a medial/lateral line segment is established on thethree-dimensional model of the patient's relevant bone. Themedial/lateral line segment is defined or otherwise selected so as toextend from a point lying on the medial surface of the patient's bone toa point lying on lateral surface of the patient's bone. The medialsurface point and the lateral surface point may be selected so as todefine the substantially maximum local medial/lateral width of thepatient's bone in some embodiments.

In step 64, an anterior/posterior line segment is established on thethree-dimensional model of the patient's relevant bone. Theanterior/posterior line segment is defined or otherwise selected so asto extend from a point lying on the anterior surface of the patient'sbone to a point lying on posterior surface of the patient's bone. Theanterior surface point and the posterior surface point may be selectedso as to define the substantially maximum local anterior/posterior widthof the patient's bone in some embodiments.

The reference point from which the reference contour will be scaled isdefined in step 66 as the intersection point of the medial/lateral linesegment and anterior/posterior line segment. As such, it should beappreciated that the medial surface point, the lateral surface point,the anterior surface point, and the posterior surface point lie on thesame plane. After the reference point is initially established in step66, the reference point is moved or otherwise translated toward an endof the patient's bone in step 68. For example, in embodiments whereinthe patient's bone is embodied as a femur, the reference point is movedinferiorly toward the distal end of the patient's femur. Conversely, inembodiments when the patient's bone is embodied as a tibia, thereference point is moved superiorly toward the proximal end of thepatient's tibia. In one embodiment, the reference point is moved adistance equal to about half the length of the anterior/posterior linesegment as determined in step 64. However, in other embodiments, thereference point may be moved other distances sufficient to compensatethe reference contour for thickness of the cartilage present on thepatient's bone.

Once the location of the reference point has been determined in step 68,the distance between the reference point and each point lying on, anddefining in part, the reference contour is increased in step 70. To doso, in one particular embodiment, each point of the reference contour ismoved a distance away from the reference point based on a percentagevalue of the original distance defined between the reference point andthe particular point on the reference contour. For example, in oneembodiment, each point lying on, and defining in part, the referencecontour is moved away from the reference point by a distance equal to apercentage value of the original distance between the reference pointand the particular point. In one embodiment, the percentage value is inthe range of about 5 percent to about thirty percent. In one particularembodiment, the percentage value is about ten percent.

Referring now to FIGS. 4-9, in another embodiment, the reference contouris scaled by manually selecting a local “high” point on the surfacecontour of the three-dimensional image of the patient's bone. Forexample, in embodiments wherein the relevant patient's bone is embodiedas a tibia as illustrated in FIGS. 4-6, the reference point 90 isinitially located on the tibial plateau high point of the tibial model92. Either side of the tibial plateau may be used. Once the referencepoint 90 is initially established on the tibial plateau high point, thereference point 90 is translated to the approximate center of theplateau as illustrated in FIG. 5 such that the Z-axis defining thereference point is parallel to the mechanical axis of the tibial model92. Subsequently, as illustrated in FIG. 6, the reference point is movedin the distal direction by a predetermined amount. In one particularembodiment, the reference point is moved is the distal direction byabout 20 millimeters, but other distances may be used in otherembodiments. For example, the distance over which the reference point ismoved may be based on the cartilage thickness value in some embodiments.

Conversely, in embodiments wherein the relevant patient's bone isembodied as a femur as illustrated in FIGS. 7-9, the reference point 90is initially located on the most distal point of the distal end of thefemoral model 94. Either condyle of the femoral model 94 may be used invarious embodiments. Once the reference point 90 is initiallyestablished on the most distal point, the reference point 90 istranslated to the approximate center of the distal end of the femoralmodel 94 as illustrated in FIG. 8 such that the Z-axis defining thereference point 90 is parallel to the mechanical axis of the femoralmodel 92. The anterior-posterior width 96 of the distal end of thefemoral model 94 is also determined. Subsequently, as illustrated inFIG. 9, the reference point is moved or otherwise translated in theproximal or superior direction by a distance 98. In one particularembodiment, the reference point is moved in the distal or superiordirection by a distance 98 equal to about half the distance 96. As such,it should be appreciated that one of a number of different techniquesmay be used to define the location of the reference point based on, forexample, the type of bone.

Referring now back to FIG. 2, once the reference contour has been scaledin step 46, the medial/lateral sides of the reference contour areadjusted in step 48. To do so, in one embodiment, the distance betweenthe reference point and each point lying on, and defining in part, themedial side and lateral side of the reference contour is decreased. Forexample, in some embodiments, the distance between the reference pointand the points on the medial and lateral sides of the scaled referencecontour are decreased to the original distance between such points. Assuch, it should be appreciated that the reference contour is offset orotherwise enlarged with respect to the anterior side of the patient'sbone and substantially matches or is otherwise not scaled with respectto the medial and lateral sides of the patient's bone.

The reference contour may also be adjusted in step 48 for areas of thepatient's bone having a reduced thickness of cartilage. Such areas ofreduced cartilage thickness may be determined based on the existence ofbone-on-bone contact as identified in a medical image, simulation, orthe like. Additionally, information indicative of such areas may beprovided by the orthopaedic surgeon based on his/her expertise. If oneor more areas of reduced cartilage thickness are identified, thereference contour corresponding to such areas of the patient's bone isreduced (i.e., scaled back or down).

Additionally, in some embodiments, one or more osteophytes on thepatient's bone may be identified; and the reference contour may becompensated for such presence of the osteophytes. By compensating forsuch osteophytes, the reference contour more closely matches the surfacecontour of the patient's bone. Further, in some embodiments, a distalend (in embodiments wherein the patient's bone is embodied as a tibia)or a proximal end (in embodiments wherein the patient's bone is embodiedas a femur) of the reference contour may be adjusted to increase theconformity of the reference contour to the surface contour of the bone.For example, in embodiments wherein the patient's bone is a femur, thesuperior end of the scaled reference contour may be reduced or otherwisemoved closer to the surface contour of the patient's femur in the regionlocated superiorly to a cartilage demarcation line defined on thepatient's femur. Conversely, in embodiments wherein the patient's boneis embodied as a tibia, an inferior end of the scaled reference contourmay be reduced or otherwise moved closer to the surface contour of thepatient's tibia in the region located inferiorly to a cartilagedemarcation line of the patient's tibia. As such, it should beappreciated that the scaled reference contour is initially enlarged tocompensate for the thickness of the patient's cartilage on the patient'sbone. Portions of the scaled reference contour are then reduced orotherwise moved back to original positions and/or toward the referencepoint in those areas where cartilage is lacking, reduced, or otherwisenot present.

Once the reference contour has been scaled and adjusted in steps 46 and48, the position of the cutting guide is defined in step 50. Inparticular, the position of the cutting guide is defined based on anangle defined between a mechanical axis of the patient's femur and amechanical axis of the patient's tibia. The angle may be determined byestablishing a line segment or ray originating from the proximal end ofthe patient's femur to the distal end of the patient's femur anddefining a second line segment or ray extending from the patient's anklethrough the proximal end of the patient's tibia. The angle defined bythese two line segments/rays is equal to the angle defined between themechanical axis of the patient's femur and tibia. The position of thebone cutting guide is then determined based on the angle between themechanical axes of the patient's femur and tibia. It should beappreciated that the position of the cutting guide defines the positionand orientation of the cutting plane of the customized patient-specificcutting block. Subsequently, in step 52, a negative contour of thecustomized patient-specific cutting block is defined based on the scaledand adjusted reference contour and the angle defined between themechanical axis of the femur and tibia.

Referring back to FIG. 1, after the model of the customizedpatient-specific orthopaedic surgical instrument has been generated inprocess step 26, the model is validated in process step 28. The modelmay be validated by, for example, analyzing the rendered model whilecoupled to the three-dimensional model of the patient's anatomy toverify the correlation of cutting guides and planes, drilling guides andplanned drill points, and/or the like. Additionally, the model may bevalidated by transmitting or otherwise providing the model generated instep 26 to the orthopaedic surgeon for review. For example, inembodiments wherein the model is a three-dimensional rendered model, themodel along with the three-dimensional images of the patient's relevantbone(s) may be transmitted to the surgeon for review. In embodimentswherein the model is a physical prototype, the model may be shipped tothe orthopaedic surgeon for validation.

After the model has been validated in process step 28, the customizedpatient-specific orthopaedic surgical instrument is fabricated inprocess step 30. The customized patient-specific orthopaedic surgicalinstrument may be fabricated using any suitable fabrication device andmethod. Additionally, the customized patient-specific orthopaedicinstrument may be formed from any suitable material such as a metallicmaterial, a plastic material, or combination thereof depending on, forexample, the intended use of the instrument. The fabricated customizedpatient-specific orthopaedic instrument is subsequently shipped orotherwise provided to the orthopaedic surgeon. The surgeon performs theorthopaedic surgical procedure in process step 32 using the customizedpatient-specific orthopaedic surgical instrument. As discussed above,because the orthopaedic surgeon does not need to determine the properlocation of the orthopaedic surgical instrument intra-operatively, whichtypically requires some amount of estimation on part of the surgeon, theguesswork and/or intra-operative decision-making on part of theorthopaedic surgeon is reduced.

Referring now to FIGS. 10-12, in one embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as afemoral cutting block 100. The cutting block 100 is configured to becoupled to a femur 124 of a patient as illustrated in FIG. 12. Thecutting block 100 includes a body 102 configured to be coupled to theanterior side of the femur 124. Two tabs 104, 106 extend orthogonallyfrom the body 102 and are configured to wrap around the end of the femur124 as discussed in more detail below. Each of the tabs 104, 106includes an inwardly curving lip 108, 110, respectively, that referencethe posterior condyles of the femur. The femoral cutting block 100includes a bone-contacting or bone-facing surface 112 defined on theinside of the body 102, the tabs 104, 106, and the lips 108, 110. Thebone-contacting surface 112 includes a negative contour 114 configuredto receive a portion of the patient's bone having a correspondingcontour. As discussed above, the negative contour 114 of thebone-contacting surface 112 allows the positioning of the cutting block100 on the patient's bone in a unique pre-determined location andorientation.

In some embodiments, the bone-contacting surface 112 of the cuttingblock 100 (as well as each bone-contacting surface discussed in regardto other embodiments) may or may not be an exact negative of thethree-dimensional bone model generated from the medical image (see step26 of algorithm 10 illustrated and described above in regard to FIG. 1).Instead, the bone-contacting surface may be a fixed offset of the bonemodel to compensate for the patient's cartilage that may or may notappear in the medical image. This offset typically varies from about 0.5millimeters to about 5 millimeters depending on location, patientgender, and disease state of the patient's joint. The cartilages isusually thickest in regions 112 b, 112 d, and 112 e. It is often thin,or non-existent in regions 112 a and 112 c. Thus the femoral cuttingblock 100 incorporates varying offsets on its bone contacting surface112.

The cutting block 100 includes a cutting guide platform 116 raised abovethe body 102. The cutting guide platform 116 includes a cutting guide118 defined therein. The platform 116 also includes a pair of anteriorpin guides 120. A pair of distal pin guides 121 is defined on the tabs104, 106. In some embodiments, the pin guides 120, 121 may be used asdrill guides to establish guide pinholes in the femur 124 of thepatient. However, in other embodiments, guide pins may not be used. Thatis, the cutting block 100 may be coupled to the femur 124 of the patientvia pressure applied by the body 102 and the tabs 104, 106 as discussedbelow.

In use, the femoral cutting block 100 is coupled to the end 122 of apatient's femur 124 as illustrated in FIG. 12. Again, because thebone-contacting surface 112 of the cutting block 100 includes negativecontour 114, the block 100 may be coupled to the femur 124 in apre-planned, unique position. When so coupled, the tabs 104, 106 wraparound the distal end 126 of the femur 124 and the lips 108, 110 of thetabs 104, 106 wrap around the posterior side of the femur 124.Additionally, when the block 100 is coupled to the patient's femur 124,a portion of the anterior side of the femur 124 is received in thenegative contour 112 of the body 102, a portion of the distal end 126 isreceived in the negative contour 112 of the tabs 104, 106, and a portionof the posterior side of the femur 124 is received in the negativecontour (if any) of the lips 108, 110. As such, the anterior, distal,and posterior surfaces of the femur 124 are referenced by the femurcutting block 100. The body 102, the tabs 104, 106, and the lips 108,110 of the femoral cutting block 100 cooperate to secure the instrument100 to the femur 124. That is, the body 102, the tabs 104, 106, and thelips 108, 110 apply an amount of pressure to the femur 124 to hold theblock 100 in place. However, in other embodiments, a number of guidepins (not shown) may be inserted into the pin guides 120, 121 and intothe femur 124 to secure the femoral cutting block 100 to the femur 124.Furthermore, pin guides 120, 121 may be used to create holes in thefemur 124 that are useful references in future procedural steps, such asorienting a re-cut block (not shown) or a chamfer block (not shown).

After the block 100 has been secured to the patient's femur 124, theorthopaedic surgeon may use the femoral cutting block to resect apre-planned amount of the femur 124. That is, the bone cut made usingthe cutting guide 118 corresponds to the cutting plane determined duringthe fabrication of the cutting block 100 (see process step 24 ofalgorithm 10 described above in regard to FIG. 1). It should beappreciated that because the cutting guide platform 116 is raised abovethe body 102, the depth of the cutting guide 118 is increased, whichprovides stability to the blade of the orthopaedic bone saw or othercutting device during use.

Referring now to FIGS. 13-15, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as afemoral cutting block 150. The cutting block 150 is configured to becoupled to a femur 154 of a patient as illustrated in FIG. 15. Thecutting block 150 includes a body 156 having an anterior wall 158 and adistal wall 160. During use, the anterior wall 158 is configured tocontact an anterior side of the femur 154 and the distal wall 160 isconfigured to contact a distal end of the femur 154 as discussed in moredetail below. Each of the walls 158, 160 of the cutting block 150includes a bone-contacting or bone-facing surface 162, 164, and an outersurface 166, 168, respectively. A negative contour 170 is defined in thebone-contacting surfaces 162, 164. The negative contour 170 isconfigured to receive a portion of the patient's femur 154 having acorresponding contour. As discussed above, the negative contour 170 ofthe bone-contacting surface surfaces 162, 164 allows the positioning ofthe cutting block 150 on the patient's femur 154 in a uniquepre-determined location and orientation.

The cutting block 150 includes a cutting guide 172 defined in theanterior wall 158. Illustratively, the cutting guide 172 is a capturedcutting guide. The femoral cutting block 150 also includes an indent orrecess 167 that indicates to the surgeon a recommended location on theblock 150 to hold while positioning the block. The femoral cutting block150 also includes a number of pin guides 174. The pin guides 174 areused as drill guides to establish guide pin holes in the femur 154 ofthe patient. A number of guide pins (not shown) may then be insertedinto the pin guides 174 and the femur 154 to secure the cutting block150 to the femur 154.

In use, the femoral cutting block 150 is coupled to the distal end 176of the patient's femur 154 as illustrated in FIG. 15. Again, because thebone-contacting surfaces 162, 164 of the cutting block 150 includes thenegative contour 170, the block 150 may be coupled to the femur 154 in apre-planned, unique position. When so coupled, a portion of the anteriorside of the femur 154 is received in the negative contour 170 of theanterior wall 158 of the block 150 and a portion of the distal end ofthe femur 154 is received in the negative contour 170 of the distal wall160 of the block 150. After the femoral cutting block 150 has beencoupled to the patient's femur 154, the orthopaedic surgeon may resectthe femur 154 using the cutting block 150. It should be appreciated thatthe shape of the distal wall 160 allows the surgeon to evaluate therotation and position of the final orthopaedic implant. That is, becausethe distal wall 160 does not completely cover the condyles of thepatient's femur, the orthopaedic surgeon can visibly observe theposition of the femur 154 and the cutting block 150. Additionally, thebone-contacting or bone-facing surface 162 of the distal wall 160 formsan extended guide for the saw blade of the orthopaedic bone saw or othercutting device, which may reduce the likelihood of scything.

Referring now to FIGS. 16-18, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as afemoral cutting block 200. The cutting block 200 is configured to becoupled to a femur 204 of a patient as illustrated in FIG. 18. Thecutting block 200 includes a body 202 having an anterior wall 206 and apair of distal tabs 208, 210 extending out from the anterior wall 206.During use, the anterior wall 206 is configured to contact an anteriorside of the femur 204 and the distal tabs 208, 210 are configured toextend over the distal end of the femur 204 as discussed in more detailbelow. The anterior wall 206 includes a bone-contacting or bone-facingsurface 212 and an outer surface 214. Each of the distal tabs 208, 210include a substantially planar bone-facing surface 216, 218 and an outersurface 220, 222, respectively. A negative contour 224 is defined in thebone-contacting surfaces 212 of the anterior wall of the body 202. Thenegative contour 224 is configured to receive a portion of the patient'sfemur 204 having a corresponding contour. As discussed above, thenegative contour 224 of the bone-contacting surface 212 allows thepositioning of the cutting block 200 on the patient's femur 204 in aunique pre-determined location and orientation.

The cutting block 200 includes a cutting guide 226 defined in theanterior wall 206. The thickness of the anterior wall 206 around thecutting guide 226 is increased relative to other portions of the wall206 to increase the depth of the cutting guide 226. Illustratively, thecutting guide 226 is a captured cutting guide. The femoral cutting block200 also includes a number of pin guides 228 defined in the anteriorwall 206 and each distal tab 208, 210. The pin guides 228 are used asdrill guides to establish guide pin holes in the femur 204 of thepatient. Illustratively, the pin guides 228 are divergent to prevent thecutting block 200 from loosening under the vibrations of an orthopaedicbone saw. A number of guide pins (not shown) may then be inserted intothe pin guides 228 and the femur 204 to secure the cutting block 200 tothe femur 204. In one particular embodiment, the pin guides 228 locatedon the distal tabs 208, 210 are used only as drill guides to establishpin holes in the femur 204 for subsequent orthopaedic instruments.

In use, the femoral cutting block 200 is coupled to the distal end 230of the patient's femur 204 as illustrated in FIG. 18. Again, because thebone-contacting surface 212 of the cutting block 200 includes thenegative contour 224, the block 200 may be coupled to the femur 204 in apre-planned, unique position. When so coupled, a portion of the anteriorside of the femur 204 is received in the negative contour 224 of theanterior wall 206 of the block 200 and the distal tabs 208, 210 extendover the end of the femur 204. In one particular embodiment, the distaltabs 208, 210 extend over the end of the femur 204, but do not contactthe surface of the femur. As such, only the anterior side of the femur204 is referenced. Additionally, in the illustrative embodiment, thetabs 208, 210 extend form the anterior wall 206 at an angle such thatthe femoral cutting block 200 is offset to one side (e.g., the medialside) of the patient's femur 204 when coupled thereto. After the femoralcutting block 200 has been coupled to the patient's femur 204, theorthopaedic surgeon may resect the femur 204 using the cutting block200. It should be appreciated that the increased thickness of theanterior wall 206 and resulting increased depth of the cutting guide 226may improve the stability of the saw blade of the orthopaedic bone sawor other cutting device.

Referring now to FIGS. 19-21, in another embodiment, a customizedpatient-specific orthopaedic surgical instrument 250 includes apatient-universal femoral cutting block 252 and a patient-specific,disposable insert 254 removably coupled to the femoral cutting block252. The femoral cutting block 252 includes an anterior wall 256 and adistal tab 258. The cutting block 250 is configured to be coupled to afemur 255 of a patient as illustrated in FIG. 21. During use, theanterior wall 256 is configured to confront the anterior side of thefemur 255 and the distal tab 258 is configured to confront the distalend of the femur 255 as discussed in more detail below.

The patient-specific insert 254 includes an anterior platform 260, aposterior clip or arcuate bracket 262, and a pair of distal feet 264,266. The platform 260, clip 262, and feet 264, 266 are configured to beremovably coupled to the femoral cutting block 252. In particular, theplatform 260 is removably coupled to a bone-facing surface 268 of theanterior wall 256. The platform 260 includes a bone-contacting surface270 having a negative contour 272 defined therein. The negative contour272 of the platform 260 is configured to receive a portion of ananterior side of the patient's femur 255. The clip 262 is coupled to theplatform 260 and extends therefrom in an inwardly curving arc. The clip262 also includes a bone-contacting surface 274 having a negativecontour 276 defined therein. The negative contour 276 of the clip 262 isconfigured to receive a portion of a posterior condyle of the patient'sfemur 255. The feet 264, 266 are removably coupled to a bone-facingsurface 278 of the distal tab 262 of the block 252. Each of the feet264, 266 includes a bone-contacting surface 280, 282, respectively. Eachof the bone-contacting surface 280, 282 includes a negative contour 284,286, respectively, defined therein. The feet 264, 266 are positioned onthe distal tab 258 such that the feet 264, 266 contact the distal end ofthe femur 255. That is, the negative contours 284, 286 are configured toreceive portions of the distal end of the femur. As discussed above, thenegative contours 272, 276, 284, 286 of the bone-contacting surfacesurfaces 270, 274, 280, 282 allows the positioning of the instrument 250on the patient's femur 255 in a unique pre-determined location andorientation.

The cutting block 252 includes a cutting guide 288 defined in theanterior wall 256. Illustratively, the cutting guide 288 is a capturedcutting guide. The femoral cutting block 252 also includes a number ofpin guides 290. The pin guides 290 are used as drill guides to establishguide pin holes in the femur 255 of the patient. A number of guide pins(not shown) may then be inserted into the pin guides 290 and the femur255 to secure the customized patient-specific surgical instrument 250 tothe patient's femur 255. The cutting guide 288 and the pin guides 290also extend through the patient-specific insert 254.

In use, the patient-specific insert 254 is initially coupled to thefemoral cutting block 252. The customized patient-specific surgicalinstrument 250 may then be coupled to the distal end 292 of thepatient's femur 255 as illustrated in FIG. 21. Again, because thebone-contacting surface surfaces 270, 274, 280, 282 of thepatient-specific insert 254 includes the respective negative contours272, 276, 284, 286, the instrument 250 may be coupled to the femur 255in a pre-planned, unique position. When so coupled, a portion of theanterior side of the femur 255 is received in the negative contour 272of the platform 260 of the insert 254. The clip 262 wraps around themedial side of the distal end 292 of the patient's femur 255. A portionof the posterior medial condyle of the patient's femur is received inthe negative contour 276 of the clip 262. Additionally, each of the feet264, 266 contact the distal end of the condyles of the patient's femur.A portion of the distal condyles is received in the negative contours284, 286 of the feet 264, 266, respectively. After the instrument 250has been coupled to the patient's femur 255, the orthopaedic surgeon mayresect the femur 255 using the instrument 250. After the orthopaedicsurgical procedure is completed, the patient-specific insert 254 may bediscarded. The femoral cutting block 252 may be sterilized and reused insubsequent surgical procedures with a new patient-specific insert.

In other embodiments, the clip 262 may be oriented to reference theproximal surface of the posterior condyle of the femur 255 asillustrated in FIG. 22. That is, the clip 262 may be angled proximallyrelative to the femoral cutting block 252. As discussed above, the clip262 also includes the bone-contacting surface 274, which includes thenegative contour 276 configured to receive a corresponding contour ofthe proximal posterior condyle of the femur 255. It should beappreciated that the position of the clip 262 provides space for orotherwise avoids interfering with particular soft tissue such particularligaments of the patient's joint.

Referring now to FIGS. 23-25, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as atibial cutting block 300. The cutting block 300 is configured to becoupled to a tibia 304 of a patient as illustrated in FIG. 25. Thecutting block 300 includes a body 302 having an anterior wall 306 and apair of tabs 308, 310 extending out from the anterior wall 306. Duringuse, the anterior wall 306 is configured to contact an anterior side ofthe tibia 304 and the tabs 308, 310 are configured to extend over themedial and lateral condyles of the tibia 304 as discussed in more detailbelow. The anterior wall 306 includes a bone-contacting or bone-facingsurface 312 and an outer surface 314. A negative contour 316 is definedin the bone-contacting surface 312 of the anterior wall 306. Each of thetabs 308, 310 includes a footpad 309, 311 extending downwardly from anend of the tabs 308, 310. Each of the footpads 309, 311 includes abone-contacting or bone-facing surface 318, 320, respectively. Anegative contour 326, 328 is defined in the bone-contacting surfaces318, 320 of the tabs 308, 310, respectively. Each of the negativecontours 316, 326, 328 is configured to receive a portion of thepatient's tibia 304. For example, the negative contour 316 of theanterior wall 306 is configured to receive a portion of the anteriorside of the patient's tibia 304. Similarly, the negative contours 326,328 of the tabs 308, 310 are configured to receive a portion of theproximal end of the patient's tibia 304. As discussed above, thenegative contours 316, 326, 328 allow the positioning of the tibialcutting block 300 on the patient's tibia 304 in a unique pre-determinedlocation and orientation.

The cutting block 300 includes a cutting guide 330 defined in theanterior wall 306. Because the anterior wall 306 is designed to wraparound the anterior side of the patient's tibia 304, the length of thecutting guide 300 is increased. The tibial cutting block 300 alsoincludes a number of pin guides 332 defined in the anterior wall 306.The pin guides 332 are used as drill guides to establish guide pin holesin the tibia 304 of the patient. A number of guide pins (not shown) maythen be inserted into the pin guides 332 and the tibia 304 to secure thecutting block 300 and/or other non-patient specific instruments (notshown) to the tibia 304.

In use, the tibial cutting block 300 is coupled to the proximal end 334of the patient's tibia 304 as illustrated in FIG. 25. Again, because thebone-contacting surfaces 312, 318, 320 of the cutting block 300 includesthe negative contours 316, 326, 328, the cutting block 300 may becoupled to the tibia 304 in a pre-planned, unique position. When socoupled, a portion of the anterior side of the tibia 304 is received inthe negative contour 316 of the anterior wall 306 and a portion of theproximal end of the tibia 304 is received in the negative contours 318,320 of the footpads 309, 311 of the tabs 308, 310. As such, the anteriorside and the proximal side of the patient's tibia 304 are referenced bythe cutting block 300. After the tibial cutting block 300 has beencoupled to the patient's femur 304, the orthopaedic surgeon may resectthe tibia 304 using the cutting block 300.

Referring now to FIGS. 26-28, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as atibial cutting block 350. The cutting block 350 is configured to becoupled to a tibia 354 of a patient as illustrated in FIG. 28. Thecutting block 350 includes a body 352 having an anterior wall 356 and apair of tabs 358, 360 extending out from the anterior wall 306. Duringuse, the anterior wall 356 is configured to contact an anterior side ofthe tibia 354 and the tabs 358, 360 are configured to extend over theproximal end of the tibia 354 as discussed in more detail below. Theanterior wall 356 includes a bone-contacting or bone-facing surface 362and an outer surface 364. A negative contour 366 is defined in thebone-contacting surface 362 of the anterior wall 356. Similarly, each ofthe tabs 358, 360 includes a bone-contacting or bone-facing surface 368,370 and an outer surface 372, 374, respectively. A negative contour 376,378 is defined in the bone-contacting surfaces 368, 370 of the tabs 358,360, respectively. Each of the outer surfaces 372, 374 of the tabs 358,360 have a downward slope to reduce the likelihood of contact betweenthe tabs 358, 360 and the femur of the patient when the tibia cuttingblock 350 is secured to the patient's tibia 354. Each of the negativecontours 366, 376, 378 is configured to receive a portion of thepatient's tibia 354. For example, the negative contour 366 of theanterior wall 356 is configured to receive a portion of the anteriorside of the patient's tibia 354. Similarly, the negative contours 376,378 of the tabs 358, 360 are configured to receive a portion of theproximal end of the patient's tibia 354. As discussed above, thenegative contours 366, 376, 378 allow the positioning of the tibialcutting block 350 on the patient's tibia 354 in a unique pre-determinedlocation and orientation.

The cutting block 350 includes a cutting guide 380 defined in theanterior wall 356. Because the anterior wall 356 is designed to wraparound the anterior side of the patient's tibia 354, the length of thecutting guide 380 is increased. Additionally, the block 350 includes acutting guide support 382 extending outwardly from the anterior wall 356below the cutting guide 380. The cutting guide support 382 extends orincreases the effective depth of the cutting guide 380, which mayincrease the stability of a bone saw blade of an orthopaedic bone saw orother cutting device during use of the block 350.

The tibial cutting block 350 also includes a number of pin guides 384defined in the anterior wall 356. The pin guides 384 are used as drillguides to establish guide pin holes in the tibia 354 of the patient. Anumber of guide pins (not shown) may then be inserted into the pinguides 384 and the tibia 354 to secure the cutting block 350 to thetibia 354.

In use, the tibial cutting block 350 is coupled to the distal end 366 ofthe patient's tibia 354 as illustrated in FIG. 28. Again, because thebone-contacting surfaces 362, 368, 370 of the cutting block 350 includesthe negative contours 366, 376, 378, the cutting block 350 may becoupled to the tibia 354 in a pre-planned, unique position. When socoupled, a portion of the anterior side of the tibia 354 is received inthe negative contour 366 of the anterior wall 356 and a portion of theproximal end of the tibia 364 is received in the negative contours 376,378 of the tabs 358, 360. As such, the anterior side and the proximalside of the patient's tibia 354 are referenced by the cutting block 350.Additionally, in some embodiments, the anterior wall 356 is relievedlaterally to provide room for the patellar tendon during use of theblock 350. That is, in some embodiments, the anterior wall 356 includesa notched out region 388 configured to reduce the likelihood of contactof the block 350 and the patellar tendon. After the tibial cutting block350 has been coupled to the patient's femur 354, the orthopaedic surgeonmay resect the tibia 354 using the cutting block 350.

Referring now to FIGS. 29-30, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as acutting block 400. The cutting block 400 is configured to be coupled toa bone 402, such as the patient's femur or tibia, as illustrated in FIG.30. The cutting block includes a body 404 having a bone-contacting orbone-facing surface 406 and an outside surface 408. The bone-contactingsurface 406 includes a negative contour 410 configured to receive aportion of the patient's bone having a corresponding contour. Asdiscussed above, the negative contour 410 of the bone-contacting surface406 allows the positioning of the cutting block 400 on the patient'sbone in a unique pre-determined location and orientation.

The cutting block 400 also includes a number of pin guides 412. In use,the pin guides 412 are used as drill guides to establish guide pin holesin the bone of the patient for securing a number of guide pins (notshown) to the bone. The cutting block 400 may then be coupled andsecured to the patient's bone 402 via the guide pins. The cutting block400 also includes a cutting guide 414 defined in the body 404 of theblock 400. Illustratively, the cutting guide 414 is a non-captured oropen cutting guide. That is, the cutting guide 414 is defined by asidewall 416 of the body 404 of the cutting block 400. However, in otherembodiments, the cutting guide 414 may be embodied as a captured cuttingguide.

In use, the cutting block 400 is coupled to the end 418 of a patient'sbone 402 as illustrated in FIG. 30. Again, because the bone-contactingsurface 406 of the cutting block 400 includes negative contour 410, theblock 400 may be coupled to the patient's bone 402 in a pre-planned,unique position. When so coupled, a portion of the anterior side of thebone 402 is received in the negative contour 410. Again, because thebone-contacting surface 406 of the cutting block 400 includes thenegative contour 410, the block 400 may be coupled to the bone 402 in apre-planned, unique position. The cutting block 400 may be secured tothe bone 402 via use of a number of guide pins (not shown) received inthe pin guides 412 and the bone 402. After the cutting block 400 hasbeen secured to the patient's bone 402, the orthopaedic surgeon may usethe cutting block 400 to resect a pre-planned amount of the bone 402.That is, the bone cut made using the cutting guide 414 corresponds tothe cutting plane determined during the fabrication of the cutting block400 (see process step 24 of algorithm 10 described above in regard toFIG. 1).

In some embodiments, the customized patient-specific orthopaedicsurgical instrument may be formed from a number of separate pieces. Forexample, as illustrated in FIGS. 31-32, the customized patient-specificorthopaedic surgical instrument may be embodied as a cutting block 450including an anterior wall piece 452 and an end wall piece 454 separatefrom the anterior wall piece 454.

The anterior wall piece 452 includes a bone-contacting or bone-facingsurface 456 and an outside surface 458. The bone-contacting surface 456includes a negative contour 460 configured to receive a portion of thepatient's bone having a corresponding contour. The anterior wall piece452 also includes a number of apertures 462 defined therethough andconfigured to receive a number of fasteners or securing devices 466,such as pins, bolts, or the like, to facilitate the coupling of theanterior wall piece 452 to the end wall piece 454. The anterior wallpiece 452 also includes a cutting guide 468. Illustratively, the cuttingguide 468 is a captured cutting guide, but may be embodied as anon-captured or open cutting guide in other embodiments.

The end wall piece 454 includes a bone-contacting or bone-facing surface470 and an outside surface 472. The bone-contacting surface 470 includesa negative contour 474 configured to receive a portion of the patient'sbone having a corresponding contour. The end wall piece 454 alsoincludes a number of apertures 476 defined in a sidewall 478. Theapertures 476 are located in the sidewall 478 corresponding to theposition of the apertures 462 of the anterior wall piece 452 such thatthe wall pieces 452, 454 may be coupled together via the securingdevices 466 as discussed below.

Each of the wall pieces 454, 456 also includes a number of pin guides480. In use, the pin guides 480 are used as drill guides to establishguide pin holes in the bone of the patient for securing a number ofguide pins (not shown) to the bone. The cutting block 450 may then becoupled and secured to the patient's bone 482 via the guide pins.

In use, the cutting block 450 is configured to be constructed inside theincision site of the patient. That is, the orthopaedic surgeon mayinsert the anterior wall piece 452 and the end wall piece 454 into theincision site of the patient. Once so inserted, the surgeon may couplethe wall pieces 452, 454 together using the securing device 466 tothereby form the cutting block 450. The cutting block 450 may then becoupled to the bone 482 of the patient. When so coupled, a portion ofthe anterior side of the bone 482 is received in the negative contour460 and a portion of the end of the bone is received in the negativecontour 474. Again, because the bone-contacting surfaces 456, 470 of thecutting block 450 include the negative contours 460, 474, the block 450may be coupled to the bone 482 in a pre-planned, unique position. Thecutting block 450 may be secured to the bone 482 via use of a number ofguide pins (not shown) received in the pin guides 480 and the bone 482.After the cutting block 450 has been secured to the patient's bone 482,the orthopaedic surgeon may use the cutting block 450 to resect apre-planned amount of the bone 482. That is, the bone cut made using thecutting guide 468 corresponds to the cutting plane determined during thefabrication of the cutting block 450 (see process step 24 of algorithm10 described above in regard to FIG. 1).

Referring now to FIG. 33, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as acutting block 500. The cutting block 500 is configured to be coupled toa bone 502, such as femur or tibia, of a patient. The cutting block 500includes a body 504. As shown in FIG. 33, the body 504 is configured tohave a relatively small thickness. The body 504 includes abone-contacting or bone-facing surface 506 and an outer surface 508. Thebone-contacting surface 506 includes a negative contour 510 configuredto receive a portion of the patient's bone 502 having a correspondingcontour. As discussed above, the negative contour 510 of thebone-contacting surface 506 allows the positioning of the cutting block500 on the patient's bone in a unique pre-determined location andorientation.

The cutting block 500 also includes a number of pin guides 512. In use,the pin guides 512 are used as drill guides to establish guide pin holesin the bone of the patient for securing a number of guide pins (notshown) to the bone. The cutting block 500 may then be coupled andsecured to the patient's bone via the guide pins. The cutting block 500also includes a captured cutting guide 514. The captured cutting guide514 is extended outwardly from the body 504 such that the depth of thecutting guide 514 is increased.

In use, the cutting block 500 is configured to be coupled to a patient'sbone 502, such as the femur or tibia. Again, because the bone-contactingsurface 506 of the cutting block 500 includes the negative contour 510,the block 500 may be coupled to the bone 502 in a pre-planned, uniqueposition. The cutting block 500 may be secured to the bone 502 via useof a number of guide pins (not shown) received in the pin guides 512 andthe bone 502. It should be appreciated that the reduced thickness of thebody 504 may increase the ability of the surgeon to position the cuttingblock 500 in the knee joint of the patient. After the cutting block 500has been secured to the patient's bone 502, the orthopaedic surgeon mayuse the cutting block 500 to resect a pre-planned amount of the bone502. It should also be appreciated that because the cutting guide 514has an increased depth, the stability of the bone saw blade of theorthopaedic bone saw or other cutting device may be increased.

Referring now to FIG. 34, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as acutting block 550. The cutting block 550 is configured to be coupled toa bone 552, such as femur or tibia, of a patient. The cutting block 550includes a body 554 having a bone-contacting or bone-facing surface 556and an outer surface 558. The bone-contacting surface 556 includes anegative contour 560 configured to receive a portion of the patient'sbone 552 having a corresponding contour. As discussed above, thenegative contour 560 of the bone-contacting surface 556 allows thepositioning of the cutting block 550 on the patient's bone in a uniquepre-determined location and orientation.

The cutting block 550 also includes a number of pin guides 562, 564. Inuse, the pin guides 562, 564 are used as drill guides to establish guidepin holes in the bone of the patient for securing a number of guide pins(not shown) to the bone. The cutting block 550 may then be coupled andsecured to the patient's bone via the guide pins. The pin guides 562 arepositioned substantially orthogonal to outside surface 558 of the body554 of the cutting block 500. Conversely, the pin guides 564 arepositioned at an angle with respect to the outside surface 558 of thebody 554. The cutting block 550 also includes a captured cutting guide566.

In use, the cutting block 550 is configured to be coupled to a patient'sbone 552, such as the femur or tibia. Again, because the bone-contactingsurface 556 of the cutting block 550 includes the negative contour 560,the block 550 may be coupled to the bone 552 in a pre-planned, uniqueposition. The cutting block 500 may be secured in one of twoconfigurations relative to the patient's bone. That is, the pin guides562 may be used to position the block 500 with respect to the patient'sbone 502 such that a planar cut may be made with the cutting guide 566.Alternatively, the pin guides 564 may be used to position the block 550at an angle with respect to the patient's bone 552 such that an angularor inclined cut may be performed on the patient's bone.

Referring now to FIGS. 35-36, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as a5-in-1 cutting block 600. The cutting block 600 is configured to becoupled to a bone 602, such as femur or tibia, of a patient asillustrated in FIG. 36. The cutting block 600 includes a body 604 havinga bone-contacting or bone-facing surface 606 and an outer surface 608.The bone-contacting surface 606 includes a negative contour 610configured to receive a portion of the patient's bone 602 having acorresponding contour. As discussed above, the negative contour 610 ofthe bone-contacting surface 606 allows the positioning of the cuttingblock 600 on the patient's bone 602 in a unique pre-determined locationand orientation. As shown in FIGS. 35 and 36, the cutting block 600 isgenerally U-shaped and is configured to reference features on theanterior, distal, and posterior sides of the patient's bone.Specifically, the cutting block 600 has a customized patient-specificnegative contour 610 defined in each of an anterior plate 630 which isconfigured to receive a portion of the anterior side of the patient'sbone, a distal plate 632 which is configured to receive a portion of thedistal side of the patient's bone, and a posterior plate 634 which isconfigured to receive a portion of the posterior side of the patient'sbone.

The cutting block 600 also includes a number of pin guides 612. In use,the pin guides 612 are used as drill guides to establish guide pinholesin the bone 602 of the patient for securing a number of guide pins (notshown) to the bone. The cutting block 600 may then be coupled andsecured to the patient's bone 602 via the guide pins.

The cutting block 600 also includes five captured cutting guides 614,616, 618, 620, 622. The illustrative cutting guide 614 is a distalcutting guide, the cutting guide 616 is an anterior cutting guide, andthe cutting guide 622 is a posterior cutting guide. The cutting guides618, 620 are angled cutting guides used to prepare the femoral chamfer.It should be appreciated that the cutting guides 614, 616, 618, 620, 622allow the orthopaedic surgeon to perform up to five different bone cutsusing the same cutting block 600.

In use, the cutting block 600 is configured to be coupled to a patient'sbone 602, such as the femur or tibia. Again, because the bone-contactingsurface 606 of the cutting block 600 includes negative contour 610, theblock 600 may be coupled to the bone 602 in a pre-planned, uniqueposition. The cutting block 600 may be secured to the bone 602 via useof a number of guide pins (not shown) received in the pin guides 612 andthe bone 602. After the cutting block 600 has been secured to thepatient's bone 602 as illustrated in FIG. 36, the orthopaedic surgeonmay use the block 600 to perform any one of a number of resections ofthe bone 602 using one or more of the cutting guides 614, 616, 618, 620,622. It should be appreciated that, in some embodiments, a singlecutting block 600 may be used to orient and complete all femoral bonecuts required for a total knee arthroplasty (TKA).

Referring now to FIG. 37, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument 650 may be embodied asa pair of bone-cutting blocks 652, 654. The bone-cutting block 652 is afemoral cutting block and is configured to be coupled to a femur 656 ofthe patient. The bone-cutting block 654 is a tibial cutting block and isconfigured to be coupled to a tibia 658 of the patient. The bone-cuttingblock 652 includes a bone-contacting or bone-facing surface 660 having anegative contour (not shown) matching a portion of the contour of thefemur 656. Similarly, the bone-cutting block 654 includes abone-contacting or bone-facing surface 662 having a negative contour(not shown) matching a portion of the contour of the tibia 658. Asdiscussed above, the negative contours of the blocks 652, 654 allow thepositioning of the patient-specific cutting blocks 652, 654 on thepatient's respective bone in a unique pre-determined location andorientation.

The femoral cutting block 652 includes a pair of pin guides 664. In use,the pin guides 664 are used as drill guides to establish guide pin holesin the femur 656. The cutting block 652 also includes a cutting guide666. Illustratively, the cutting guide 666 is a captured cutting guide,but may be embodied as a non-captured or open cutting guide in otherembodiments. Similarly, the tibial cutting block 654 includes a pair ofpin guides 668 and a cutting guide 670. As discussed above, the cuttingguides 666, 670 are used to guide a bone saw blade or other cuttingdevice.

The cutting blocks 652, 654 also form a pair of trial blocks, such thatthe orthopaedic surgeon may analyze the motion of the patient's kneewhile performing the resectioning. That is, the distal end 672 of thefemoral cutting block 652 includes a pair of trial condylar surfaces674, 676 which have concave outer profiles that resemble the naturalcondyles of a femur. The proximal end 678 of the tibial cutting block654 includes a pair of trial articular surfaces 680, 682 which haveconvex outer profiles which resemble the natural articular surfaces ofthe condyles of a tibia. The trial articular surfaces 680, 682 areconfigured to receive the trial condylar surfaces 674, 676 of the tibialcutting block 652.

In use, the cutting blocks 652, 654 are configured to be coupled topatient's femur 656 and tibia 658, respectively. Again, because each ofthe blocks 652, 654 include the respective negative contours, the blocks652, 654 may be coupled to the respective bone 656, 658 in apre-planned, unique position such that the cutting guides 666, 670 arepositioned in a desired location relative to the respective bone 656,658. After the cutting blocks 652, 654 have been secured to the femur656 and tibia 658 of the patient, the orthopaedic surgeon may resect thefemur 656 and the tibia 658 using the cutting guides 666, 670 with abone saw or other cutting device. To do so, the surgeon may insert abone saw blade of the bone saw into the cutting guide 666, 670. Itshould be appreciated that because the position of the cutting guides666, 670 are pre-determined due to the configuration of the respectivebone cutting blocks 652, 654, any bone cuts made using thepatient-specific cutting blocks 652, 654 correspond to the predeterminedbone cutting planes (see process step 24 of algorithm 10 described abovein regard to FIG. 1). Additionally, the surgeon may manipulate the jointto analysis the movement of the joint using the trial-shaped ends of theblocks 652, 654.

Referring now to FIG. 38, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument 700 may be embodied asa pair of bone-cutting blocks 702, 704. The bone-cutting block 702 is afemoral cutting block and is configured to be coupled to a femur 706 ofthe patient. The bone-cutting block 704 is a tibial cutting block and isconfigured to be coupled to a tibia 708 of the patient. The bone-cuttingblock 702 includes a bone-contacting or bone-facing surface 710 having anegative contour (not shown) matching a portion of the contour of thefemur 706. Similarly, the bone-cutting block 704 includes abone-contacting or bone-facing surface 712 having a negative contour(not shown) matching a portion of the contour of the tibia 708. Asdiscussed above, the negative contours of the blocks 702, 704 allow thepositioning of the patient-specific cutting blocks 702, 704 on thepatient's respective bone in a unique pre-determined location andorientation.

The femoral cutting block 702 includes a pair of pin guides 714. In use,the pin guides 714 are used as drill guides to establish guide pin holesin the femur 706. The cutting block 702 also includes a cutting guide716. Illustratively, the cutting guide 716 is a captured cutting guide,but may be embodied as a non-captured or open cutting guide in otherembodiments. Similarly, the tibial cutting block 704 includes a pair ofpin guides 718 and a cutting guide 720. As discussed above, the cuttingguides 716, 720 are used to guide a bone saw blade or other cuttingdevice.

The cutting blocks 702, 704 are coupled to each other via a mechanicallinkage 722. The mechanical linkage 722 may be embodied as any number ofthreaded bolts, gears, and the like for performing the functionsdescribed herein. Namely, rotation of the threaded shafts of themechanical linkage 722 in one direction or the other moves the cuttingblocks 702, 704 away from or toward each other. A pair of thumbwheels724 are operably coupled to the mechanical linkage 722. The thumbwheels724 are usable by the surgeon to operate the linkage 722 to move thecutting blocks 702, 704 away from or toward each other by, for example,rotating the threaded shafts of the mechanical linkage 722. That is, thethumbwheels 724 may be operated to move the femoral cutting block 702 inthe direction of arrow 726 and the tibial cutting block 704 in thedirection of arrow 728. In some embodiments, the mechanical linkage 722may be positioned in a housing 730 positioned between the cutting blocks702, 704.

In use, the cutting blocks 702, 704 are configured to be coupled topatient's femur 706 and tibia 708, respectively. Again, because each ofthe blocks 702, 708 include the respective negative contours, the blocks702, 708 may be coupled to the respective bone 706, 708 in apre-planned, unique position such that the cutting guides 716, 720 arepositioned in a desired location relative to the respective bone 706,708. After the cutting blocks 702, 704 have been secured to the femur706 and tibia 708 of the patient, the orthopaedic surgeon may operatethe thumbwheels 724 to adjust the relative position of the cuttingblocks 702, 704 (e.g., move the blocks 702, 704 toward or away from eachother).

After the position of the cutting blocks 702, 704 relative to each otherhas been adjusted, the surgeon may resect the femur 706 and the tibia708 using the cutting guides 716, 720 with a bone saw or other cuttingdevice. It should be appreciated that because the position of thecutting guides 716, 720 are pre-determined due to the configuration ofthe respective bone cutting blocks 702, 704 any bone cuts made using thepatient-specific cutting blocks 702, 704 correspond to the predeterminedbone cutting planes (see process step 24 of algorithm 10 described abovein regard to FIG. 1).

Referring now to FIG. 39, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as acutting block 750 configured to be coupled to or otherwise contact thefemur 752 and/or tibia 753 of the patient. The cutting block 750includes a body 754 having a bone-contacting or bone-facing surface 756and an outer surface 758. In the illustrative embodiment shown in FIGS.39-41, the body 754 is monolithic. The bone-contacting surface 756includes a negative contour 760 configured to receive a portion of thepatient's bone 752, 753 having a corresponding contour. As discussedabove, the negative contour 760 of the bone-contacting surface 756allows the positioning of the cutting block 750 on the patient's bone ina unique pre-determined location and orientation.

The cutting block 750 also includes a number of pin guides 762. In theillustrative embodiment of FIG. 39, the pin guides 762 are positioned onthe body 754 of the cutting block 750 such that the cutting block 750may be secured to the femur 752. That is, the guides 762 may be used asa drill guide to establish guide pin holes in the femur 752 of thepatient for securing a number of guide pins 764 to the femur 752. Thecutting block 750 may then be coupled and secured to the femur 752 viathe guide pins 764. The cutting block 750 also includes a tibial cuttingguide 766. Illustratively, the cutting guide 766 is a captured cuttingguide, but may be embodied as a non-captured or open cutting guide inother embodiments.

In use, the cutting block 750 is configured to be coupled to thepatient's femur 752 and tibia 753. That is, the guides 762 may be usedto secure the cutting block 750 to the femur using a number of guidepins 764. The cutting block 750, however, is not secured to thepatient's tibia 753. Again, because the bone-contacting surface 756 ofthe block 750 includes the negative contour 760, the block 750 may becoupled to the femur 752 and tibia 753 in a pre-planned, uniqueposition. After the cutting block 750 has been secured to the patient'sfemur 752 via the guide pins 764, the surgeon may resect the patient'stibia 753 using the cutting guide 766. Because the cutting block 750references the femur 752 and the tibia 753, the stability of the block750 may be increased relative to cutting blocks that reference only thetibia 753. That is, because the femur 752 provides a larger surface areato reference with the block 750 relative to referencing only the tibia753, the stability of the cutting block 750 may be improved.Additionally, in the illustrative embodiment of FIG. 39, the cuttingblock 750 is secured to the femur 752, rather than the tibia, to furtherstabilize the block.

In other embodiments, the cutting block 750 may be secured to the tibia753 rather than the femur 752 as illustrated in FIG. 40. In suchembodiments, the cutting block 750 includes a tibial pin guide 786 forsecuring the block 750 to the tibia 753 via a number of guide pings 788.Although the cutting block 750 is secured to the tibia 753, thestability of the block 750 may be increased relative to cutting blocksthat reference only the tibia 753 because the cutting block 750references the femur 752 and the tibia 753 as discussed above.

Additionally, in other embodiments, the cutting block 750 may beconfigured to be secured to the femur 752 and the tibia 753 asillustrated in FIG. 41. In such embodiments, the cutting block includesthe femoral pin guides 762 and the tibial pin guides 766. Additionally,the cutting block 750 may include a femoral cutting guide 790 inaddition to the tibia cutting guide 766. In such embodiments, thecutting block 750 may be used to resect the femur 752 and/or the tibia753. Additionally, in such embodiment, the cutting block 750 may includea tongue 792 extending from the body 754. The tongue 792 is configuredto be received between the femur 752 and the tibia 753 to furtherstabilize the cutting block 750. Again, because the cutting block 750references the femur 752 and the tibia 753, the stability of the block750 may be increased relative to cutting blocks that reference only thefemur 752 or the tibia 753.

Referring now to FIGS. 42-44, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument 800 may be embodied asa pair of bone-cutting blocks 802, 804. The bone-cutting block 802 is afemoral cutting block and is configured to be secured to a femur 806 ofthe patient. The bone-cutting block 804 is a tibial cutting block and isconfigured to be coupled to or otherwise confront a tibia 808 of thepatient. The cutting blocks 802, 804 are coupled to each via a hinge 810secured to an end 812, 814 of each block 802, 804, respectively.

The femoral cutting block 802 includes a bone-contacting or bone-facingsurface 816 having a negative contour 818 matching a portion of thecontour of the femur 806. As discussed above, the negative contour 818of the femoral cutting block 802 allows the positioning of thepatient-specific femoral cutting block 802 on the patient's femur 806 ina unique pre-determined location and orientation. The tibia block 804also includes a bone-contacting or bone-facing surface 820. In someembodiments, the bone-contacting surface 820 may be substantiallyplanar. Alternatively, in other embodiments, the bone-contacting surface820 may include a negative contour (not shown) matching a portion of thecontour of the patient's tibia 808.

The femoral cutting block 802 includes a pair of pin guides 822. In use,the pin guides 822 are used as drill guides to establish guide pin holesin the femur 806. The femoral cutting block 802 also includes a distalfemoral cutting guide 824. Illustratively, the cutting guide 824 is acaptured cutting guide, but may be embodied as a non-captured or opencutting guide in other embodiments. Similarly, the tibial cutting block804 includes a proximal tibial cutting guide 826. Additionally, in someembodiments, the tibial cutting block 804 may include a posteriorfemoral cutting guide 828.

In use, the femoral cutting block 802 is coupled to the patient's femur806. Again, because the cutting block 802 includes the negative contour818, the femoral cutting block 802 may be coupled to the femur 806 in apre-planned, unique position. The femoral cutting block 802 is securedto the patient's femur 806 in extension using the pin guides 822. Whilethe patient's leg is in extension, the orthopaedic surgeon may resectthe distal end of the femur 806 using the femoral cutting guide 824. Theorthopaedic surgeon may then position the patient's leg in flexion asillustrated in FIG. 43. When the patient's leg is moved to flexion, thetibial cutting block 804 follows the tibia 808 and is positionedrelative to the tibia 808 such that the surgeon may perform a proximalcut on the tibia 808 using the tibial cutting guide 826. In embodimentswherein tibial cutting block 804 also includes the posterior femoralcutting guide 828, the orthopaedic surgeon may resect the posteriorcondyles of the femur 806 using the guide 828.

In some embodiments, the tibial cutting block 804 may be coupled to thefemoral cutting block 802 via a hinge 830 positioned on the side of thefemoral cutting block 802 as illustrated in FIG. 44. That is, thefemoral cutting block 802 and the tibial cutting block 804 may becoupled by the hinge 830, which is positioned toward the medial orlateral side of the blocks 802, 804. In such a configuration, thefemoral cutting block 802 may be configured to wrap around the distalend of the femur 806 as shown in FIG. 44 to provide additional stabilityto the cutting blocks 802, 804.

Referring now to FIGS. 45-46, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as amilling guide 850. The milling guide 850 is configured to be coupled toa bone 852, such as femur or tibia, of a patient. The milling guide 850includes a bone-contacting or bone-facing surface 856 and an outersurface 858. The bone-contacting surface 856 includes a negative contour860 (see FIG. 46) configured to receive a portion of the patient's bone852 having a corresponding contour. As discussed above, the negativecontour 860 of the bone-contacting surface 856 allows the positioning ofthe milling guide 850 on the patient's bone in a unique pre-determinedlocation and orientation.

The milling guide 850 also includes a number of apertures 862. Theapertures 862 are sized to guide the burr 864 of a milling machine. Inuse, the milling guide 850 may be coupled to the end of a patient's bone852. Again, because the bone-contacting surface 856 of the milling guide850 includes the negative contour 860, the guide 850 may be coupled tothe bone 852 in a pre-planned, unique position. After the milling guide850 has been coupled to the bone 852, the burr 864 may be inserted intoone of the apertures 862 and operated to mill the bone as desired.

Referring now to FIG. 47, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as aburring guide 900. The burring guide 900 is configured to be coupled tothe end of a burring or milling machine. For example, the burring guide900 may be coupled to the shaft 902 of the burring machine via a bushing904. The busing 904 allows the shaft 902 and the burr end 906 of theburring machine to rotate while maintaining the burring guide 900 in afixed position against the bone.

The burring guide 900 includes a body 910 having a bone-contacting orbone-facing surface 912. The bone-facing surface 912 includes a negativecontour 913 defined therein. The negative contour 913 of thebone-contacting surface 912 is configured to receive a portion of thepatient's bone 914 when the burring guide 900 is contacted thereto.Additionally, the bone-facing surface 912 includes an aperture 916 inwhich the burr end 906 is received.

Referring now to FIG. 48, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as aburring block 950. The burring block 950 is configured to be coupled toa bone 952, such as femur or tibia, of a patient. The burring block 950includes a body 954 having a bone-contacting or bone-facing surface 956and an outer surface 958. The bone-contacting surface 956 includes anegative contour (not shown) configured to receive a portion of thepatient's bone 952 having a corresponding contour. As discussed above,the negative contour of the bone-contacting surface 956 allows thepositioning of the burring block 950 on the patient's bone 952 in aunique pre-determined location and orientation.

The burring block 950 also includes a number of pin guides 960. In use,the pin guides 960 are used as drill guides to establish guide pin holesin the bone of the patient for securing a number of guide pins (notshown) to the bone. The burring block 950 may then be coupled andsecured to the patient's bone 952 via the guide pins.

The burring block 950 also includes a burring aperture 962 defined inthe body 954. The burring aperture 962 is sized to allow the burring end964 of a burr machine to be inserted therein. That is, the burringaperture 962 has a width 966 sufficient to accept the diameter of theburring end 964 in addition to the portion of the bone 952 that extendstherein. The inner wall 968, which defines the aperture 962, forms aburring guide. That is, during use, the shaft 970 of the burring machinemay be run along the inner wall 968 as a guide to generate a planarresection on the bone 952.

Referring now to FIGS. 49-52, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument 1000 includes aligament balancer 1002 and a patient-specific femoral cutting block 1004coupled to the ligament balancer 1002. The ligament balancer 1002includes a tibial base plate 1006 and a pair of femoral paddles 1008,1010, which are received in corresponding cylindrical housings 1012,1014. A pair of knobs or other control devices 1016, 1018 are positionedat the base of the housings 1012, 1014 and are operatively coupled tothe femoral paddles 1008, 1010. The knobs 1016, 1018 may be used toindependently move each femoral paddles 1008, 1010 away from or towardthe tibial base plate 1006 and tense the knee joint under proper tensionto cause the femur to move to its optimal rotation with respect to thetibia.

The cutting block 1004 is configured to be coupled to a bone 1020, suchas femur or tibia, of a patient as illustrated in FIG. 50. The cuttingblock 1004 includes a body 1022 having a bone-contacting or bone-facingsurface 1024 and an outer surface 1026. The bone-contacting surface 1024includes a negative contour 1028 configured to receive a portion of thepatient's bone 1020 having a corresponding contour. As discussed above,the negative contour 1028 of the bone-contacting surface 1024 allows thepositioning of the cutting block 1004 on the patient's bone 1020 in aunique pre-determined location and orientation.

The cutting block 1004 also includes a femoral cutting guide 1030. Theillustrative cutting guide 1030 is a captured cutting guide, but may beembodied as a non-captured or open cutting guide in other embodiments.The cutting block 1004 also includes a number of pin guides 1032 In use,the pin guides 1032 are used as drill guides to establish guide pinholes in the bone 1020 of the patient for securing a number of guidepins (not shown) to the bone.

The cutting block 1004 is coupled to the ligament balancer 1002 via abracket 1034. The bracket 1034 includes a pair of apertures 1036 inwhich are received a pair of pins 1038. The body 1022 of the cuttingblock 1004 includes a pair of inwardly curving, elongated apertures1040. The pins 1038 are received in the elongated apertures 1040 of thecutting block 1004 and secured into the bone 1020 of the patient.Additionally, the bracket 1034 orients the pair of pins 1038 in a linethat is parallel to proximal surface of the tibia 1103. It should beappreciated that the elongated apertures 1040 allow the cutting block1004 to be rotated relative to the ligament balancer 1002 as describedbelow.

In use, the cutting block 1004 is coupled to the end of a patient's bone1020, such as the femur. Again, because the bone-contacting surface 1024includes the negative contour 1028, the block 1004 may be coupled to thebone 1020 in a pre-planned, unique position. The cutting block 1004 maybe secured to the bone 1020 via use of the guide pins 1038. That is, theguide pins 1038 may be inserted into the elongated apertures 1040 andinto the bone 1020 of the patient. The ligament balancer 1002 may thenbe coupled to the patient's bony anatomy. To do so, the base 1006 isplaced on the proximal end of the patient's tibia and each paddle 1008,1010 engages a condyle of the patient's femur 1020. The apertures 1036of the bracket 1034 receive portions of the guide pins 1038, whichextend from the elongated openings 1040 of the cutting block 1004. Theorthopaedic surgeon may then adjust the ligament balancer as desired andresect the patient's bone 1020 using the femoral cutting guide 1030.

In other embodiments, the ligament balancer 1002 may be configured toreference an intramedullar rod 1102 as illustrated in FIG. 51-52. Insuch embodiments, the bracket 1034 includes a receiver 1104 configuredto couple to the rod 1102. The intramedullar rod 1102 references theintramedullary canal of the femur 1020. The bracket 1034 of the ligamentbalancer 1002 provides a pivot point 1106 about which the femur 1020 mayrotate while maintaining the pins 1038 in an approximate parallelorientation relative to the proximal surface 1103 of the patient's tibia

Referring now to FIGS. 53-54, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as afemoral cutting block 1200. The cutting block 1200 is configured to becoupled to a femur 1204 of a patient as illustrated in FIG. 54. Thecutting block 1200 includes a body 1202 having an anterior wall 1206 anda pair of distal tabs 1208, 1210 extending out from the anterior wall1206. During use, the anterior wall 1206 is configured to contact ananterior side of the femur 1204 and the distal tabs 1208, 1210 areconfigured to extend over the distal end of the femur 1204 as discussedin more detail below. The tabs 1208, 1210 each include a footpad 1216,1218, respectively. The footpads 1216, 1218 are embodied as oval rings,each having a central recess 1217. As discussed in more detail below,the footpads 1216, 1218 are negatively contoured to contact a portion ofthe distal end of the femur 1204. In other embodiments, the footpads1216, 1218 may have other configurations such as a circular shape.

The anterior wall 1206 includes a bone-contacting or bone-facing surface1212 and an outer surface 1214. A negative contour 1224 is defined inthe bone-contacting surfaces 1212 of the anterior wall of the body 1202.The negative contour 1224 is configured to receive a portion of thepatient's femur 1204 having a corresponding contour. As discussed above,the negative contour 1224 of the bone-contacting surface 1212 allows thepositioning of the cutting block 1200 on the patient's femur 1204 in aunique pre-determined location and orientation.

The cutting block 1200 includes a cutting guide 1226 defined in theanterior wall 1206. The thickness of the anterior wall 1206 around thecutting guide 1226 is increased relative to other portions of the wall1206 to increase the depth of the cutting guide 1226. Illustratively,the cutting guide 1226 is a captured cutting guide. The femoral cuttingblock 1200 also includes a number of pin guides 1228 defined in theanterior wall 1206 and each distal tab 1208, 1210. The pin guides 1228are used as drill guides to establish guide pin holes in the femur 1204of the patient. Illustratively, the pin guides 1228 are divergent toprevent the cutting block 1200 from loosening under the vibrations of anorthopaedic bone saw. A number of guide pins (not shown) may then beinserted into the pin guides 1228 and the femur 1204 to secure thecutting block 1200 to the femur 1204. In one particular embodiment, thepin guides 1228 located on the distal tabs 1208, 1210 are used only asdrill guides to establish pin holes in the femur 1204 for subsequentorthopaedic instruments.

In use, the femoral cutting block 1200 is coupled to the distal end 1230of the patient's femur 1204 as illustrated in FIG. 54. Again, becausethe bone-contacting surface 1212 of the cutting block 1200 includes thenegative contour 1224, the block 1200 may be coupled to the femur 1204in a pre-planned, unique position. When so coupled, a portion of theanterior side of the femur 1204 is received in the negative contour 1224of the anterior wall 1206 of the block 1200 and the distal tabs 1208,1210 extend over the end of the femur 1204. The footpads 1216, 1218 ofthe tabs 1208, 1210 contact the distal end of the patient's femur 1204.However, the portions of the femur 1204 over which the recess 1217 ispositioned are not referenced. That is, the recess 1217 may or may notreceive portions of the patient's femur 1204. As such, the footpads1216, 1218 may be positioned relative to the body 1202 of the cuttingblock 1200 such that the recess 1217 are positioned over portions of thefemur 1204 that are not visible in the medical images (see process steps12, 20, 24 of the algorithm 10 illustrated in and described above inregard to FIG. 1). As such, those portions of the femur 1204 that arenot reproduced in the medical images because, for example, oflimitations of the imaging modality or aspects of the patient'sparticular bony anatomy, are not referenced to improve the fitting ofthe block 1200. After the femoral cutting block 1200 has been coupled tothe patient's femur 1204, the orthopaedic surgeon may resect the femur1204 using the cutting block 1200.

Referring now to FIGS. 55-57, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as afemoral cutting block 1300. The cutting block 1300 is configured to becoupled to a femur of a patient similar to the cutting block 100described above. The cutting block 1300 includes a body 1302 configuredto be coupled to the anterior side of the patient's femur and two armsor tabs 1304, 1306, which extend away from the body 1302 in aposteriorly direction. The tabs 1304, 1306 are configured to wrap arounda distal end of the femur as discussed in more detail below. Each of thetabs 1304, 1306 includes an inwardly-curving or otherwise superiorlyextending lip 1308, 1310, respectively, which references the posteriorcondyles of the femur. The cutting block 1300 may be formed from anysuitable material. For example, the cutting block 1300 may be formedfrom a material such as a plastic or resin material. In someembodiments, the cutting block 1300 may be formed from a photo-curableor laser-curable resin. In one particular embodiment, the cutting block1300 is formed from a Vero resin, which is commercially available fromObjet Geometries Ltd. of Rehovot, Israel using a rapid prototypefabrication process. However, the cutting block 1300 may be formed fromother materials in other embodiments. For example, in another particularembodiment, the cutting block 1300 is formed from a polyimidethermoplastic resin, such as a Ultem resin, which is commerciallyavailable from Saudi Basic Industries Corporation Innovative Plastics ofRiyhadh, Saudi Arabia.

The body 1302 includes a bone-contacting or bone-facing surface 1312 andan outer surface 1314 opposite the bone-facing surface 1312. The outersurface 1314 includes a depression or recessed area 1316, which providesan indication to a surgeon where to apply pressure to the body 1302 whencoupling the cutting block 1300 to the patient's femur. Additionally, anumber of guide pin holes or passageways 1318 are defined through thebody 1302 and have a diameter sized to receive respective guide pins tosecure the block 1300 to the patient's femur. In some embodiments, oneor more of the guide pin holes 1318 may be oblique or otherwise angledwith respect to the remaining guide pin holes 1318 to further secure theblock 1300 to the patient's bone.

The body 1302 includes a modular cutting guide 1320. That is, the body1302 includes a cutting guide receiver slot 1322 in which the cuttingguide 1320 is received. A latch 1324 or other locking device secures thecutting guide 1320 in place in the cutting guide receiver slot 1322. Assuch, one of a number of different cutting guides 1320 having a cuttingguide slot 1326 defined in various offset positions may be coupled tothe body 1302 to allow a surgeon to selectively determine the amount ofbone of the patient's bone is removed during the bone cutting procedure.For example, a cutting guide 1320 having a cutting guide slot 1326offset by +2 millimeters, with respect to a neutral reference cuttingguide 1320, may be used if the surgeon desires to remove a greateramount of the patient's bone. The cutting guide 1320 may be formed fromthe same material as the body 1302 or from a different material. In oneparticular embodiment, the cutting guide 1320 is formed form a metallicmaterial such as stainless steel.

The bone-facing surface 1312 of the body 1302 includes a negativecontour 1328 configured to receive a portion of the anterior side of thepatient's femur having a corresponding contour. As discussed above, thecustomized patient-specific negative contour 1328 of the bone-contactingsurface 1312 allows the positioning of the cutting block 1300 on thepatient's femur in a unique pre-determined location and orientation.

As discussed above, the arms or tabs 1304, 1306 extend posteriorly fromthe body 1300 to define a U-shaped opening 1305 therebetween. The tabs1304, 1306 may extend from the body the same distance or a differentdistance. For example, as shown in FIG. 56, the tab 1304 extends fromthe body 1300 a distance 1330 and the tab 1306 extends from the body1330 a distance 1332, which is greater than the distance 1330. Each ofthe tabs 1304, 1306 includes a respective guide pin holes or passageways1338, 1340 defined therethrough. The guide pin holes 1338, 1340 have adiameter sized to receive respective guide pin to further secure theblock 1300 to the patient's femur.

The tabs 1304, 1306 include a bone-contacting or bone-facing surface1340, 1342, respectively, and an outer surface 1344, 1346, respectively,opposite the bone-facing surface 1340, 1342. The bone-facing surface1340 of the tab 1304 includes a negative contour 1348 configured toreceive a portion of the distal side of the patient's femur having arespective corresponding contour. Similarly, the bone-facing surface1342 of the tab 1306 includes a negative contour 1350 configured toreceive a portion of the distal side of the patient's femur having arespective corresponding contour.

The lips 1308, 1310 of the tabs 1304, 1306 also include abone-contacting or bone-facing surface 1352, 1354, respectively, and anouter surface 1356, 1358, respectively, opposite the bone-facing surface1352, 1354. The bone-facing surface 1352 of the lip 1308 includes anegative contour 1360 configured to receive a portion of the posteriorside of the patient's femur having a respective corresponding contour.Similarly, the bone-facing surface 1354 of the lip 1310 includes anegative contour 1362 configured to receive a portion of the distal sideof the patient's femur having a respective corresponding contour. Eachthe lips 1308, 1310 include a lateral slot 1364 that forms a saw relieveslot and is configured to provide an amount of clearance for the bonesaw blade used to remove a portion of the patient's bone. That is,during the performance of the orthopaedic surgical procedure, a distalend of the bone saw blade may be received in the slot 1364.

In some embodiments, the negative contours 1328, 1348, 1350, 1356, 1358of the bone-contacting surfaces 1312, 1340, 1342, 1352, 1354 of thecutting block 1300 may or may not match the corresponding contoursurface of the patient's bone. That is, as discussed above, the negativecontours 1328, 1348, 1350, 1356, 1358 may be scaled or otherwise resized(e.g., enlarged) to compensate for the patient's cartilage or lackthereof.

In use, the femoral cutting block 1300 is coupled to the distal end ofthe patient's femur. Again, because the bone-contacting surfaces 1312,1340, 1342, 1352, 1354 of the cutting block 1300 include the negativecontours 1328, 1348, 1350, 1356, 1358 the block 1300 may be coupled tothe patient's femur in a pre-planned, unique position. When so coupled,the tabs 1304, 1306 wrap around the distal end of the patient's femurand the lips 1308, 1310 of the tabs 1304, 1306 wrap around the posteriorside of the patient's femur. Additionally, when the block 1300 iscoupled to the patient's femur, a portion of the anterior side of thefemur is received in the negative contour 1328 of the body 1302, aportion of the distal side of the patient's femur is received in thenegative contours 1348, 1350 of the tabs 1304, 1306, and a portion ofthe posterior side of the femur is received in the negative contours1356, 1358 of the lips 1308, 1310. As such, the anterior, distal, andposterior surfaces of the patient femur are referenced by the femoralcutting block 1300.

Referring now to FIGS. 58-60, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as afemoral cutting block 1400. The cutting block 1400 is configured to becoupled to a femur of a patient similar to the cutting block 100described above. The cutting block 1400 includes a body 1402 configuredto be coupled to the anterior side of the patient's femur and two armsor tabs 1404, 1406, which extend away from the body 1402 in aposteriorly direction. The tabs 1404, 1406 are configured to wrap arounda distal end of the femur as discussed in more detail below. Each of thetabs 1404, 1406 includes an inwardly-curving or otherwise superiorlyextending lip 1408, 1410, respectively, which references the posteriorcondyles of the femur. Similar to the cutting block 1300, the cuttingblock 1400 may be formed from any suitable material. For example, thecutting block 1400 may be formed from a material such as a plastic orresin material. In one particular embodiment, the cutting block 1400 isformed from Vero resin using a rapid prototype fabrication process.However, the cutting block 1400 may be formed from other materials inother embodiments. For example, in another particular embodiment, thecutting block 1400 is formed from a polyimide thermoplastic resin, suchas a Ultem resin, which is commercially available from Saudi BasicIndustries Corporation Innovative Plastics of Riyhadh, Saudi Arabia.

The body 1402 includes a bone-contacting or bone-facing surface 1412 andan outer surface 1414 opposite the bone-facing surface 1412. The outersurface 1414 includes a number of guide holes or passageways 1416defined therethrough. A guide pin bushing 1418 is received in each guidehole 1416. The guide pin bushings 1418 include an internal passageway1420 sized to receive a respective guide pin to secure the block 1400 tothe patient's femur. As shown in FIG. 60, the guide passageways 1416extends from the outer surface 1414 to the bone-facing surface 1412 andis counterbored on the bone-facing surface 1412. That is, the passageway1416 has an opening 1422 on the bone-facing surface 1412 having adiameter greater than the diameter of an opening 1424 on the outersurface 1414.

The cutting guide 1400 includes a cutting guide 1430 secured to the body1402. In one particular embodiment, the cutting guide 1430 is overmoldedto the body 1402. The cutting guide 1430 includes a cutting guide slot1432. The cutting guide 1430 may be formed from the same material as thebody 1402 or from a different material. In one particular embodiment,the cutting guide 1430 is formed from a metallic material such asstainless steel. The body 1402 also includes a window or opening 1434defined therethough. The opening 1434 allows a surgeon to visualize thepositioning of the block 1400 on the patient's femur by viewing portionsof the femur through the opening 1434. Additionally, the opening 1434may reduce the amount of air pockets or other perfections created duringthe fabrication of the block 1400. In the illustrative embodiment, theopening 1434 extends from the cutting guide 1400 to a point moresuperior than the superior-most point 1436 of the guide pin bushings1418. However, in other embodiments, the cutting block 1400 may includewindows or openings formed in the body 1402 having other shapes andsizes.

The bone-facing surface 1412 of the body 1402 includes a negativecontour 1438 configured to receive a portion of the anterior side of thepatient's femur having a corresponding contour. As discussed above, thecustomized patient-specific negative contour 1438 of the bone-contactingsurface 1412 allows the positioning of the cutting block 1400 on thepatient's femur in a unique pre-determined location and orientation.

The tabs 1404, 1406 include a bone-contacting or bone-facing surface1440, 1442, respectively, and an outer surface 1444, 1446, respectively,opposite the bone-facing surface 1440, 1442. The bone-facing surface1440 of the tab 1404 includes a negative contour 1448 configured toreceive a portion of the distal side of the patient's femur having arespective corresponding contour. Similarly, the bone-facing surface1442 of the tab 1406 includes a negative contour 1450 configured toreceive a portion of the distal side of the patient's femur having arespective corresponding contour.

As discussed above, the arms or tabs 1404, 1406 extend posteriorly fromthe body 1400 to define a U-shaped opening 1405 therebetween. The tabs1404, 1406 may extend from the body 1400 the same distance or adifferent distance. For example, as shown in FIG. 59, the tab 1404extends from the body 1400 a distance 1452 and the tab 1406 extends fromthe body 1400 a distance 1454, which is less than the distance 1452.Each of the tabs 1404, 1406 includes a respective guide hole orpassageway 1460 defined therethrough. A guide pin bushing 1462 isreceived in each guide hole 1460. The guide pin bushings 1462 include aninternal passageway 1464 sized to receive a respective guide pin tofurther secure the block 1400 to the patient's femur. Similar to theguide passageways 1416, the guide passageways 1460 may be counterboredon the bone-facing surface 1440, 1442 of the tabs 1404, 1406.

The lips 1408, 1410 of the tabs 1404, 1406 also include abone-contacting or bone-facing surface 1472, 1474, respectively, and anouter surface 1476, 1478, respectively, opposite the bone-facing surface1472, 1474. The bone-facing surface 1472 of the lip 1408 includes anegative contour 1480 configured to receive a portion of the posteriorside of the patient's femur having a respective corresponding contour.Similarly, the bone-facing surface 1474 of the lip 1410 includes anegative contour 1482 configured to receive a portion of the distal sideof the patient's femur having a respective corresponding contour. Eachthe lips 1408, 1410 includes a lateral slot 1484 that forms a sawrelieve slot and is configured to provide an amount of clearance for thebone saw blade used to remove a portion of the patient's bone. That is,during the performance of the orthopaedic surgical procedure, a distalend of the bone saw blade may be received in the slot 1484.

In some embodiments, the negative contours 1438, 1448, 1450, 1480, 1482of the bone-contacting surfaces 1412, 1440, 1442, 1472, 1474 of thecutting block 1400 may or may not match the corresponding contoursurface of the patient's bone. That is, as discussed above, the negativecontours 1438, 1448, 1450, 1480, 1482 may be scaled or otherwise resized(e.g., enlarged) to compensate for the patient's cartilage or lackthereof.

In use, the femoral cutting block 1400 is coupled to the distal end ofthe patient's femur. Again, because the bone-contacting surfaces 1412,1440, 1442, 1472, 1474 of the cutting block 1400 include the negativecontours 1438, 1448, 1450, 1480, 1482, the block 1400 may be coupled tothe patient's femur in a pre-planned, unique position. When so coupled,the tabs 1404, 1406 wrap around the distal end of the patient's femurand the lips 1408, 1410 of the tabs 1404, 1406 wrap around the posteriorside of the patient's femur. Additionally, when the block 1400 iscoupled to the patient's femur, a portion of the anterior side of thefemur is received in the negative contour 1438 of the body 1402, aportion of the distal side of the patient's femur is received in thenegative contours 1448, 1450 of the tabs 1404, 1406, and a portion ofthe posterior side of the femur is received in the negative contours1480, 1482 of the lips 1408, 1410. As such, the anterior, distal, andposterior surfaces of the patient femur are referenced by the femoralcutting block 1400.

Referring now to FIGS. 61-63, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as atibial cutting block 1500. The cutting block 1500 is configured to becoupled to a tibia of a patient similar to the cutting block 300described above. The cutting block 1500 includes a body 1502 configuredto be coupled to the anterior side of the patient's tibia and two armsor tabs 1504, 1506, which extend away from the body 1502 in aposteriorly direction. The tabs 1504, 1506 are configured to wrap over aproximal end of the tibia as discussed in more detail below. The cuttingblock 1500 may be formed from any suitable material. For example, thecutting block 1500 may be formed from a material such as a plastic orresin material. In one particular embodiment, the cutting block 1500 isformed from Vero resin using a rapid prototype fabrication process.However, the cutting block 1500 may be formed from other materials inother embodiments. For example, in another particular embodiment, thecutting block 1500 is formed from a polyimide thermoplastic resin, suchas a Ultem resin, which is commercially available from Saudi BasicIndustries Corporation Innovative Plastics of Riyhadh, Saudi Arabia.

The body 1502 includes a bone-contacting or bone-facing surface 1512 andan outer surface 1514 opposite the bone-facing surface 1512. The outersurface 1514 includes a depression or recessed area 1516, which providesan indication to a surgeon where to apply pressure to the body 1502 whencoupling the cutting block 1500 to the patient's tibia. Additionally, anumber of guide pin holes or passageways 1518 are defined through thebody 1502 and have a diameter sized to receive respective guide pins tosecure the block 1500 to the patient's tibia. In some embodiments, oneor more of the guide pin holes 1518 may be oblique or otherwise angledwith respect to the remaining guide pin holes 1518 to further secure theblock 1500 to the patient's bone.

The body 1502 includes a modular cutting guide 1520. That is, the body1502 includes a cutting guide receiver slot 1522 in which the cuttingguide 1520 is received. A latch 1524 or other locking device secures thecutting guide 1520 in place in the cutting guide receiver slot 1522. Assuch, one of a number of different cutting guides 1520 having a cuttingguide slot 1526 defined in various offset positions may be coupled tothe body 1502 to allow a surgeon to selectively determine the amount ofbone of the patient's bone is removed during the bone cutting procedure.For example, a cutting guide 1520 having a cutting guide slot 1526offset by +2 millimeters, with respect to a neutral reference cuttingguide 1520, may be used if the surgeon desires to remove a greateramount of the patient's bone. The cutting guide 1520 may be formed fromthe same material as the body 1502 or from a different material. In oneparticular embodiment, the cutting guide 1520 is formed form a metallicmaterial such as stainless steel.

The bone-facing surface 1512 of the body 1502 includes a negativecontour 1528 configured to receive a portion of the anterior side of thepatient's tibia having a corresponding contour. As discussed above, thecustomized patient-specific negative contour 1528 of the bone-contactingsurface 1512 allows the positioning of the cutting block 1500 on thepatient's tibia in a unique pre-determined location and orientation.

As discussed above, the arms or tabs 1504, 1506 extend posteriorly fromthe body 1502 to define a U-shaped opening 1505 therebetween. The tabs1504, 1506 may extend from the body 1502 the same distance or adifferent distance. For example, as shown in FIG. 62, the tab 1504extends from the body 1502 a distance 1530 and the tab 1506 extends fromthe body 1502 a distance 1532, which is greater than the distance 1530.The tabs 1504, 1506 taper in the anterior-posterior direction. That is,the thickness of the tabs 1504, 1506 at an anterior end of the tabs1504, 1506 is greater than the thickness of the tabs 1504, 1506 at arespective posterior end 1507, 1509. The tapering of the tabs 1504, 1506allow the tabs 1504, 1506 to be inserted within the joint gap definedbetween the patient's femur and tibia.

The tabs 1504, 1506 include a bone-contacting or bone-facing surface1540, 1542, respectively, and an outer surface 1544, 1546, respectively,opposite the bone-facing surface 1540, 1542. The bone-facing surface1540 of the tab 1504 includes a negative contour 1548 configured toreceive a portion of the distal side of the patient's tibia having arespective corresponding contour. Similarly, the bone-facing surface1542 of the tab 1506 includes a negative contour 1550 configured toreceive a portion of the distal side of the patient's tibia having arespective corresponding contour.

In some embodiments, the negative contours 1528, 1548, 1550 of thebone-contacting surfaces 1512, 1540, 1542 of the cutting block 1500 mayor may not match the corresponding contour surface of the patient'sbone. That is, as discussed above, the negative contours 1528, 1548,1550 may be scaled or otherwise resized (e.g., enlarged) to compensatefor the patient's cartilage or lack thereof.

In use, the tibial cutting block 1500 is coupled to the proximal end ofthe patient's tibia. Again, because the bone-contacting surfaces 1512,1540, 1542 of the cutting block 1500 include the negative contours 1528,1548, 1550, the block 1500 may be coupled to the patient's tibia in apre-planned, unique position. When so coupled, the tabs 1504, 1506 wraparound the proximal end of the patient's tibia. Additionally, when theblock 1500 is coupled to the patient's femur, a portion of the anteriorside of the tibia is received in the negative contour 1528 of the body1502 and a portion of the proximal side of the patient's tibia isreceived in the negative contours 1548, 1550 of the tabs 1504, 1506. Assuch, the anterior and proximal surfaces of the patient tibia arereferenced by the tibial cutting block 1500.

Referring now to FIGS. 64-66, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as atibial cutting block 1600. The cutting block 1600 is configured to becoupled to a tibia of a patient similar to the cutting block 1500described above. The cutting block 1600 includes a body 1602 configuredto be coupled to the anterior side of the patient's tibia and two armsor tabs 1604, 1606, which extend away from the body 1602 in aposteriorly direction. The tabs 1604, 1606 are configured to wrap arounda proximal end of the tibia as discussed in more detail below. Similarto the cutting block 1500, the cutting block 1600 may be formed from anysuitable material. For example, the cutting block 1600 may be formedfrom a plastic or resin material. In one particular embodiment, thecutting block 1600 is formed from Vero resin using a rapid prototypefabrication process. However, the cutting block 1600 may be formed fromother materials in other embodiments. For example, in another particularembodiment, the cutting block 1600 is formed from a polyimidethermoplastic resin, such as a Ultem resin, which is commerciallyavailable from Saudi Basic Industries Corporation Innovative Plastics ofRiyhadh, Saudi Arabia.

The body 1602 includes a bone-contacting or bone-facing surface 1612 andan outer surface 1614 opposite the bone-facing surface 1612. The outersurface 1614 includes a number of guide holes or passageways 1616defined therethrough. A guide pin bushing 1618 is received in each guidehole 1616. The guide pin bushings 1618 include an internal passageway1620 sized to receive a respective guide pin to secure the block 1600 tothe patient's tibia. As shown in FIG. 66, the guide passageways 1616extends from the outer surface 1614 to the bone-facing surface 1612 andis counterbored on the bone-facing surface 1612. That is, the passageway1616 has an opening 1622 on the bone-facing surface 1612 having adiameter greater than the diameter of an opening 1624 on the outersurface 1614

The cutting guide 1600 includes a cutting guide 1630 secured to the body1602. In one particular embodiment, the cutting guide 1630 is overmoldedto the body 1602. The cutting guide 1630 includes a cutting guide slot1632. The cutting guide 1630 may be formed from the same material as thebody 1602 or from a different material. In one particular embodiment,the cutting guide 1630 is formed from a metallic material such asstainless steel. The body 1602 also includes a window or opening 1634 toallow a surgeon to visualize the positioning of the block 1600 on thepatient's tibia by viewing portions of the tibia through the opening1634. In the illustrative embodiment, the window 1634 is embodied as anotch 1636 defined on a superior end surface 1637 of the body 1602 ofthe cutting guide 1600. However, in other embodiments, the cutting block1600 may include windows or openings formed in the body 1602 havingother shapes and sizes.

The bone-facing surface 1612 of the body 1602 includes a negativecontour 1638 configured to receive a portion of the anterior side of thepatient's tibia having a corresponding contour and a portion of themedial side of the patient's tibia. That is, the negative contour 1638is selected such that cutting block 1600 is configured to be coupled tothe patient's tibia on an anterior-medial side. For example, asillustrated in FIG. 65, when the cutting block 1600 is secured to apatient's tibia, an angle 1639 is defined between avertically-extending, bisecting plane 1641 of the body 1602 of the block1600 and a bisecting sagittal plane 1643 of the patient's tibia. Themagnitude of the angle 1639 may be selected based on, for example, thegender or age of the patient. In one particular embodiment, the angle isin the range of about 10 degrees to about 30 degrees. In anotherparticular embodiment, the angle is about 20 degrees. As discussedabove, the customized patient-specific negative contour 1638 of thebone-contacting surface 1612 allows the positioning of the cutting block1600 on the patient's tibia in a unique pre-determined location andorientation.

The tabs 1604, 1606 include a bone-contacting or bone-facing surface1640, 1642, respectively, and an outer surface 1644, 1646, respectively,opposite the bone-facing surface 1640, 1642. The bone-facing surface1640 of the tab 1604 includes a negative contour 1648 configured toreceive a portion of the proximal side of the patient's tibia having arespective corresponding contour. Similarly, the bone-facing surface1642 of the tab 1606 includes a negative contour 1650 configured toreceive a portion of the proximal side of the patient's tibia having arespective corresponding contour.

As discussed above, the arms or tabs 1604, 1606 extend posteriorly fromthe body 1600 to define a U-shaped opening 1605 therebetween. The tabs1604, 1606 may extend from the body 1600 the same distance or adifferent distance. For example, as shown in FIG. 65, the tab 1604extends from the body 1600 a distance 1652 and the tab 1606 extends fromthe body 1600 a distance 1654, which is greater than the distance 1652.Each of the tabs 1604, 1606 includes a respective elongated opening orwindow 1660 defined therethrough. Similar to the window 1634 describedabove, the windows 1660 allow a surgeon to visualize the positioning ofthe block 1600 on the patient's tibia by viewing portions of theproximal end tibia through the opening 1660.

In some embodiments, the negative contours 1638, 1648, 1650 of thebone-contacting surfaces 1612, 1640, 1642 of the cutting block 1400 mayor may not match the corresponding contour surface of the patient'sbone. That is, as discussed above, the negative contours 1638, 1648,1650 may be scaled or otherwise resized (e.g., enlarged) to compensatefor the patient's cartilage or lack thereof.

In use, the tibial cutting block 1600 is coupled to the proximal end ofthe patient's tibia. Again, because the bone-contacting surfaces 1612,1640, 1642 of the cutting block 1600 include the negative contours 1638,1648, 1650, the block 1600 may be coupled to the patient's tibia in apre-planned, unique position. When so coupled, the tabs 1604, 1606 wraparound the proximal end of the patient's tibia. Additionally, when theblock 1600 is coupled to the patient's tibia, a portion of the anteriorside of the tibia is received in the negative contour 1638 of the body1602 and a portion of the proximal side of the patient's tibia isreceived in the negative contours 1648, 1650 of the tabs 1604, 1606.

Referring now to FIG. 67, in one embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as adrill guide instrument 2050. The drill guide instrument 2050 includes abody 2052 having a bone-contacting or bone-facing surface 2054 and anouter surface 2056. The bone-contacting surface 2054 includes a negativecontour 2058 configured to receive a portion of the patient's bonehaving a corresponding contour. As discussed above, the negative contour2058 allows the positioning of the drill guide instrument 2050 on thepatient's bone in a unique pre-determined location and orientation.Illustratively, the drill guide instrument 2050 is configured for usewith the femur of a patient, but in other embodiments, the drill guideinstrument 2050 may be configured for use with other bones of thepatient such as the tibia. The body 2052 of the drill guide instrument2050 includes a number of drill guides 2060, 2062, each having a drillguide passageway 2066 defined therethrough. Illustratively, the drillguides 2060 and corresponding drill guide passageways 2066 arepositioned on the body 2052 of the instrument 2050 to facilitate thepositioning of guide pins for a patient-universal distal femur cuttingblock while the drill guide 2062 and corresponding drill guidepassageways 2066 are positioned on the body 2052 to facilitate thepositioning of guide pins for a patient-universal 4-in-1 femur cuttingblock. However, in other embodiments, the drill guide instrument 2050may have a greater or lesser number of drill guide positioned in otherlocations on the body 2052.

In use, the illustrative drill guide instrument 2050 is configured to becoupled to the distal end of a femur 2070 of a patient as illustrated inFIG. 68. Again, because the drill guide instrument 2050 includes thenegative contour 2058, the drill guide instrument 2050 may be coupled tothe femur 2070 in a pre-planned, unique position such that the drillguides 2060, 2062 are positioned in a desired location relative to thefemur 2070. As such, because the positioning of the drill guideinstrument 2050 has been predefined based on the negative contour 2058,an orthopaedic surgeon may couple the drill guide instrument 2050 to thefemur 2070 without the need of estimating the correct location.

After the drill guide instrument 2050 is coupled to the distal end ofthe femur 2070, the orthopaedic surgeon may use the drill guides 2060,2062 to drill a number of holes or passageways 2068 in the femur 2070.After the passageways 2068 have been drilled into the femur 2070, anumber of guide pins 2072 may be inserted or threaded into thepassageways 2068. The drill guide instrument 2050 may be left in placeduring the insertion of the guide pins 2072 or may be removed priorthereto. The guide pins 2072 are inserted into the femur 2070 such thata portion of each pin 2072 extends outwardly from the femur 2070.

After the guide pins 2072 have been inserted into the femur 2070, anumber patient-universal or standard bone cutting blocks may be coupledto the femur 2070 using the guide pins 2072. For example, as illustratedin FIG. 69, a patient-universal distal cutting block 2074 and apatient-universal 4-in-1 femur-cutting block 2076 may be coupled to thefemur 2070. Each of the blocks 2074, 2076 include a guide pin passageway2075 configured to receive the portion of the corresponding guide pinthat extends outwardly from the femur 2070. Additionally, each of theblocks 2074, 2076 include one or more cutting guides. For example, theblock 2074 includes a captured cutting guide 2078. The block 2076includes a pair of angled, captured cutting guides 2080, 2082. Inaddition, the block 2076 includes a pair of non-captured cutting guides2084, 2086, which define the ends of the block 2076. In use, each of thecutting guides 2078, 2080, 2082, 2084, 2086 may be used to guide a bonesaw blade or other cutting device. To do so, the bone saw blade may beinserted into the captured guides 2078, 2080, 2082 or abutted againstthe non-captured guides 2084, 2086 to facilitate the cutting of thefemur 2070. It should be appreciated that because the position of theguide pins 2072 are pre-determined due to the configuration of the drillguide instrument 2050, any bone cuts made using the patient-universalcutting blocks 2074, 2076 correspond to the predetermined bone cuttingplanes (see process step 24 of algorithm 10 described above in regard toFIG. 1).

Referring now to FIGS. 70 and 71, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as apair of bone-cutting blocks 2102, 2104. The bone-cutting block 2102 is afemoral cutting block and is configured to be coupled to a femur 2106 ofthe patient. The bone-cutting block 2104 is a tibial cutting block andis configured to be coupled to a tibia 2108 of the patient. Thebone-cutting block 2102 includes a bone-contacting or bone-facingsurface 2110 having a negative contour (not shown) matching a portion ofthe contour of the femur 2106. Similarly, the bone-cutting block 2104includes a bone-contacting or bone-facing surface 2112 having a negativecontour (not shown) matching a portion of the contour of the tibia 2108.As discussed above, the negative contours of the blocks 2102, 2104 allowthe positioning of the patient-specific cutting blocks 2102, 2104 on thepatient's respective bone in a unique pre-determined location andorientation.

The femoral cutting block 2102 includes a pair of pin guides 2114. Inuse, the pin guides 2114 are used as drill guides to establish guide pinholes in the femur 2106. The cutting block 2102 also includes a cuttingguide 2116. Illustratively, the cutting guide 2116 is a captured cuttingguide, but may be embodied as a non-captured or open cutting guide inother embodiments. Similarly, the tibial cutting block 2104 includes apair of pin guides 2118 and a cutting guide 2120. As discussed above,the cutting guides 2116, 2120 are used to guide a bone saw blade orother cutting device.

In some embodiments, the bone-contacting surface 2110 of thebone-cutting block 2102 may also include a thumb or pressure recess2111, which is positioned on the block 2102 to correspond to a fossa ofthe patient's bone 2106. In use, the thumb recess 2111 may be used bythe surgeon to properly seat the cutting block 2102 on the patient'sbone 2106

In use, the cutting blocks 2102, 2104 are configured to be coupled topatient's femur 2106 and tibia 2108, respectively. Again, because eachof the blocks 2102, 2104 include the respective negative contours, theblocks 2102, 2104 may be coupled to the respective bone 2106, 2108 in apre-planned, unique position such that the pin guides 2114, 2118 andcutting guides 2116, 2120 are positioned in a desired location relativeto the respective bone 2106, 2108. After the blocks 2102, 2104 have beencoupled to the respective bone 2106, 2108, the orthopaedic surgeon maydrill guide pin holes into the bones 2106, 2108 using the pin guides2114, 2118 as drill guides. Guide pins 2122 may then be inserted intoeach pin guide 2114, 2118 to secure the corresponding patient-specificcutting block 2102, 2104 to the respective bone 2106, 2108. After thecutting blocks 2102, 2104 have been secured to the femur 2106 and tibia2108 of the patient, the orthopaedic surgeon may resect the femur 2106and the tibia 2108 using the cutting guides 2116, 2120 with a bone sawor other cutting device. To do so, the surgeon may insert a bone sawblade of the bone saw into the cutting guide 2116, 2120. It should beappreciated that because the position of the cutting guides 2116, 2120are pre-determined due to the configuration of the respective bonecutting blocks 2102, 2104, any bone cuts made using the patient-specificcutting blocks 2102, 2104 correspond to the predetermined bone cuttingplanes (see process step 24 of algorithm 10 described above in regard toFIG. 1).

In some instances, the orthopaedic surgeon may determine that additionalbone must be removed from the femur and/or tibia subsequent to the firstresection using the patient-specific cutting blocks 2102, 2104. In suchcases, the orthopaedic surgeon may use a pair of patient-universalre-cut blocks 2132, 2134 as shown in FIG. 71. The patient-universalrecut blocks 2132, 2134 may be coupled to the femur 2106 and the tibia2108 of the patient, respectively, using the guide pins 2122. That is,the location of the pin guides 2114, 2118 on the respectivepatient-specific cutting blocks 2102, 2104 is selected such that theguide pins 2122, once inserted into the patient's bone, may be used withpatient-universal or standard re-cut blocks. As such, new guide pins forthe re-cut blocks 2132, 2134 are not needed. Each of the re-cut blocks2132, 2134 include a grouping of guide pin holes 2136 configured toreceive the guide pins 2122. Illustratively, each grouping of the guidepin holes 2136 includes a neutral guide pin hole 2138, a plus twomillimeter guide pin hole 2140, and a minus two millimeter guide pinhole 2142. However, guide pin holes corresponding to other resectionamounts may be used in other embodiments. Additionally, as illustratedin FIG. 71, the guide pin holes 2136 include pairings of holes that maybe used to adjust the angle of the resection cut. Each of the re-cutblocks 2132, 2134 also include a captured cutting guide 2144, 2146.However, in other embodiments, the re-cut blocks 2132, 2134 may includenon-captured or open cutting guides in addition to or in place of theguides 2144, 2146.

Referring now to FIG. 72, in one embodiment, a patient-universal re-cutinstrument 2150 includes a base 2152 and a cutting block 2154 removablycoupled to the base 2152. The base 2152 includes a substantially planarbone-contacting or bone-facing surface 2156 and an outer surface 2158. Ahandle 2160 extends outwardly from the outer surface 2158 to facilitatethe positioning of the instrument 2150. The bone-contacting surface 2156is configured to contact the resected surface 2162 of a bone 2164 of thepatient as illustrated in FIG. 72.

The cutting block 2154 is secured to an end 2166 of the base 2152 via asecuring device 2168 such as a bolt, thumbscrew, or other securingdevice capable of removably coupling the block 2154 to the base 2152.The cutting block 2154 includes a captured cutting guide 2172, but mayalso include a non-captured cutting guide 2174 in some embodiments. Insuch embodiments, the non-captured cutting guide 2174 may define an endside of the cutting block 2154. The cutting guide 2172 may be defined inthe cutting block 2154 such that any amount of bone may be resected. Forexample, in one illustrative embodiment, the cutting guide 2172 isdefined in the cutting block 2154 such that two millimeters of bone isremoved during each resectioning of the bone 2164. In other embodiments,the cutting block 2154 may be configured to remove other amounts ofbone. In addition, because the cutting block 2154 is removable from thebase 2152, cutting blocks having cutting guides configured to facilitatethe removal of various amounts of bone may be selectively coupled to thebase 2152. As such, a selection of cutting blocks configured to removevarious amounts of bone during resectioning may be used with a singlebase 2152.

Referring now to FIGS. 73-76, in another embodiment, a patient-universalre-cut instrument or block 2200 includes a planar bone-contacting orbone-facing surface 2202, a lower outer surface 2204, and an upper outersurface 2206. The bone-contacting surface 2202 is configured to contactthe resected surface 2216 of a bone 2212 of the patient as illustratedin FIGS. 75 and 76. Illustratively, the re-cut block 2200 is configuredfor use with a femur of the patient, but may be configured for use withthe tibia or other bone of the patient in other embodiments. Theillustrative re-cut instrument 2200 has a substantially “L”-shape, butmay have other shapes in other embodiments configured to be coupled tothe end of a resected bone.

The re-cut instrument 2200 includes a captured cutting guide 2208defined in the upper outer surface 2206, but may also include anon-captured cutting guide 2209 in some embodiments. In suchembodiments, the non-captured cutting guide 2209 may define an end sideof the re-cut block 2200. The cutting guide 2208 may be defined in there-cut block 2200 such that any amount of bone may be resected. Forexample, in one illustrative embodiment, the cutting guide 2208 isdefined in the re-cut block 2200 such that two millimeters of bone isremoved during each resectioning of the bone 2212. In other embodiments,the re-cut block 2200 may be configured to remove other amounts of bone.

The re-cut instrument 2200 also includes a number of guide pin holes2210 as illustrated in FIG. 74. The guide pin holes 2210 are defined inthe lower outer surface 2204 of the instrument 2200 such that theinstrument 2200 may be coupled to the bone 2212 of the patient in aneutral or angled position. That is, as illustrated in FIGS. 75 and 76,the re-cut block 2200 is configured to be coupled to the bone 2212 ofthe patient using the guide pins 2220, which were secured to the bone2212 of the patient using a customized patient-specific orthopaedicsurgical instrument such as one of the bone-cutting blocks 2102, 2104described above in regard to FIGS. 70 and 71.

After the initial cut of the bone has been made using the customizedpatient orthopaedic surgical instrument, the re-cut instrument 2200 maybe coupled to the bone 2212 using the guide pins 2220. As discussedabove, the re-cut block 2200 may be coupled to the bone 2212 in aneutral orientation or in an angled orientation to facilitate straightor angled cuts, respectively. For example, if an angled cut is desired,the re-cut instrument 2200 may be coupled to the bone 2212 such that theguide pins 2220 are received in guide pin holes 2222, 2224, which areoffset relative to each other (see FIG. 74). As such, the cutting guide2208 is oriented in an angled position relative to the bone 2212 of thepatient. In some embodiments as illustrated in FIG. 76, the cuttingguide 2208 may be defined in the re-cut instrument at an angle toprovide additional angulation to the bone cut. In use, an orthopedicsurgeon may be supplied with a variety of re-cut blocks 2200, eachconfigured to remove different amounts of bone and/or cut the bone atvarious angles. For example, the re-cut blocks 2200 may be shipped tothe orthopaedic surgeon along with the customized patient-specificorthopaedic surgical instrument as discussed above in regard to processsteps 30, 32 of algorithm 10.

Referring now to FIGS. 77-80, in one embodiment, an orthopaedic surgicaltool usable with various customized patient-specific orthopaedicsurgical instruments is embodied as a bone saw tool 2300. The bone sawtool 2300 includes a bone saw 2302 and a bone saw blade 2304. The bonesaw 2300 includes a housing 2306 having a bone saw chuck 2308 configuredto receive the bone saw blade 2304 positioned on one end of the housing2306. A handle 2316 extends downwardly from the housing 2306. A user maycouple the bone saw blade 2304 to the bone saw 2302 by inserting thebone saw blade 2304 into the chuck 2308 and operating the chuck 2308 tosecure the bone saw blade 2304 to the bone saw 2302. In use, theillustrative bone saw blade chuck 2308 moves the saw blade 2304 in acutting motion. For example, in some embodiments, the bone saw bladechuck 2308 oscillates the bone saw blade 2304 along a cutting arc 2309.However, in other embodiments, the bone saw blade 2304 may be oscillatedor otherwise moved in any direction and along any cutting path dependingon the particular application and type of bone saw used.

The bone saw 2302 also includes a guide 2310 coupled to the bottom ofthe housing 2306. The guide 2310 is configured as a body having one ormore holes to receive one or more guide pins 2312 that have been coupledto a bone 2314 of a patient. In the illustrative embodiment describedherein, the guide 2310 is embodied as an elongated body having a slotdefined therein for receiving the guide pins 2312. The guide pins 2312may be coupled to the bone 2314 using a customized patient-specificorthopaedic surgical instrument such as the drill guide instrument 2050illustrated in and described above in regard to FIGS. 67-69. As such,the guide pins 2312 are coupled to the bone 2314 in a pre-determinedposition due to the configuration of the customized patient-specificorthopaedic surgical instrument such that any bone cuts made with thebone saw 2302 correspond to the predetermined bone cutting planes (seeprocess step 24 of algorithm 10 described above in regard to FIG. 1).

As discussed above, the guide 2310 is configured to receive the guidepins 2312. The guide 2310 is elongated and oriented orthogonally withrespect to the guide pins 2312 such that the pins 2312 may be receivedin the guide 2310. In use, the bone saw 2302 may be moved in amedial-lateral direction with respect to the patient's bone 2314 untilone of the guide pins 2312 contacts an inner side wall of the guide2310.

In other embodiments, the guide 2310 may be secured to the bone saw 2302via use of other devices. For example, as illustrated in FIG. 78, thehousing 2306 of the bone saw 2302 may include a shaft 2320 in someembodiments. In such embodiments, the guide 2310 may be secured to theshaft 2320 via a clamp 2322. The guide 2310 may be removably coupled tothe shaft 2320 in some embodiments. For example, the clamp 2322 mayinclude a securing device such as a bolt 2324, which may be removed torelease or remove the guide 2310 from the bone saw 2302.

As shown in FIGS. 78 and 79, the guide pins 2312 are received in theguide 2310 in use. In some embodiments, the guide 2310 may be configuredto swivel or turn with respect to the bone saw 2302. That is, the guide2310 may be coupled to the clamp 2322 via a swiveling post 2326. Assuch, during use, the bone saw 2302 may be moved in a medial-lateraldirection and swivel with respect to the guide pins 2312.

In some embodiments, the distance 2333 at which the guide pins 2312extend from the bone 2312 may vary. For example, in some embodiments,the guide pins 2312 may extend from the bone 2314 a short distance. Insuch embodiments, the guide 2310 of the bone saw 2302 may be configuredto move inwardly and outwardly with respect to the bone saw 2302 toaccommodate guide pins 2312 of various lengths. For example, asillustrated in FIG. 80, the guide 2310 may be coupled to a base 2336,which is coupled to the clamp 2322 via a rod 2330. The rod 2330 extendsthrough a spring 2332 positioned between the base of the guide 2310 andthe clamp 2324. The spring 2332 biases the rod 2330 in an extendedposition relative to the clamp 2324. However, if the guide pins 2312extend from the bone 2314 a short distance 2333, the guide 2310 may bepressed against the side of the bone 2314 during use to cause the spring2332 to be compressed to a length 2334. In response to compression ofthe spring, the guide 2310 is retracted inwardly with respect to thebone saw 2302. In some embodiments, the guide 2310 may be coupled to thebase 2336 via a swiveling post 2326. In such embodiments the guide 2310is configured to swivel or turn with respect to the bone saw 2302.

Referring now to FIG. 81, in one embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as acutting block 3100. The cutting block 3100 is configured to be coupledto a bone, such as femur or tibia, of a patient. The cutting block 3100includes a body 3102 having a bone-contacting or bone-facing surface3104 and an outer surface 3106. The bone-contacting surface 3104includes a negative contour 3108 configured to receive a portion of thepatient's bone having a corresponding contour. As discussed above, thenegative contour 3108 of the bone-contacting surface 3104 allows thepositioning of the cutting block 3100 on the patient's bone in a uniquepre-determined location and orientation.

The cutting block 3100 also includes a number of pin guides 3110. Inuse, the pin guides 3110 are used as drill guides to establish guide pinholes in the bone of the patient for securing a number of guide pins(not shown) to the bone. The cutting block 3100 may then be coupled andsecured to the patient's bone via the guide pins.

The cutting block 3100 also includes a first cutting guide 3112, asecond cutting guide 3114, and a third cutting guide 3116. Each of thecutting guides 3112, 3114, 3116 are spaced apart from each other apredetermined distance. For example, in one particular embodiment, eachof the cutting guides 3112, 3114, 3116 are spaced apart a distance ofabout two millimeters, but may be spaced apart from each other distancesin other embodiments. In some embodiments, the second cutting guide 3114is embodied as the neutral or zero offset cutting guide. That is,because the position of the cutting guide 3114 is pre-determined due tothe configuration of the cutting block 3100, any bone cuts made usingthe patient-specific cutting block 3100 correspond to the predeterminedbone cutting planes (see process step 24 of algorithm 10 described abovein regard to FIG. 1). As such, the cutting guide 3112 is spaced apartfrom the cutting guide 3114 and usable to remove a greater amount of thepatient's bone (e.g., two millimeters more) relative to the cuttingguide 3114. Similarly, the cutting guide 3116 is spaced apart from thecutting guide 3114 and usable by the surgeon to remove a lesser amountof the patient's bone (e.g., two millimeters less) relative to thecutting guide 3114.

In use, the cutting block 3100 is configured to be coupled to apatient's bone 3120, such as the femur or tibia as illustrated in FIG.82. Again, because the bone-contacting surface 3104 of the cutting block3100 includes the negative contour 3108, the block 3100 may be coupledto the bone 3120 in a pre-planned, unique position. The cutting block3100 may be secured to the bone 3120 via use of a number of guide pins(not shown) received in the pin guides 3110 and the bone 3120. In someembodiments, the cutting block 3100 may include a mechanical alignmentline or indicator 3122 and/or an anatomical alignment line or indicator3124.

After the cutting block 3100 has been secured to the patient's bone3120, the orthopaedic surgeon may perform the bone resectioning. Asdiscussed above, the surgeon may use the cutting guide 3114 to resectthe pre-planned amount of bone. That is, the bone cut made using thecutting guide 3114 corresponds to the cutting plane determined duringthe fabrication of the cutting block 3100 (see process step 24 ofalgorithm 10 described above in regard to FIG. 1). However, theorthopaedic surgeon may make an intra-operative decision based onanalysis of the bony anatomy of the patient and/or soft tissue complexto remove more or less of the patient's bone with respect to thepre-planned amount (i.e., the amount removed if the surgeon uses thecutting guide 3114). For example, the orthopaedic surgeon may use thecutting guide 3112 to remove more of the patient's bone or the cuttingguide 3116 to remove less of the patient's bone. As such, it shouldappreciated that the cutting block 3100 provides an amount ofintra-operative adjustability to the orthopaedic surgeon.

Referring now to FIG. 83, in some embodiments, the cutting block 3100may include a breakaway tab 3122 covering the cutting guide 3112 and abreakaway tab 3124 covering the cutting guide 3116. The breakaway tabs3122, 3124 may be formed from a transparent material in someembodiments. The orthopaedic surgeon may estimate the amount of bonethat will be removed when using each cutting guide 3112, 3116 by lookingthrough the transparent breakaway tabs 3122, 3124. In use, if thesurgeon decides to use one of the cutting guides 3112, 3116, the surgeonmay remove the respective breakaway tab 3122, 3124 and resect thepatient's bone 3120 using the corresponding cutting guide 3112, 3116.

Referring now to FIGS. 84-86, in one embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as acutting block 3150. The cutting block 3150 is configured to be coupledto a bone, such as femur or tibia, of a patient. The cutting block 3150includes a body 3152 having a bone-contacting or bone-facing surface3154 and an outer surface 3156. The bone-contacting surface 3154includes a negative contour 3158 configured to receive a portion of thepatient's bone having a corresponding contour. As discussed above, thenegative contour 3158 of the bone-contacting surface 3154 allows thepositioning of the cutting block 3150 on the patient's bone in a unique,pre-determined location and orientation. In some embodiments, thecutting block 3150 may also include an anterior resection line orindicator 3180 and/or a posterior resection line 3182.

The cutting block 3150 also includes a number of pin guides 3160. Inuse, the pin guides 3160 are used as drill guides to establish guide pinholes in the bone of the patient for securing a number of guide pins(not shown) to the bone. The cutting block 3150 may then be coupled andsecured to the patient's bone via the guide pins.

The cutting block 3150 also includes an aperture 3162 defined in theouter surface 3156 of the body 3152. The aperture 3162 is configured toreceive one of a number of cutting guide inserts 3164, 3166, 3168. Theillustrative aperture 3162 is rectangular in shape, but may have othershapes in other embodiments configured to receive the inserts 3164,3166, 3168. The cutting guide inserts 3164, 3166, 3168 are similarlyconfigured to be received in the aperture 3162. As such, theillustrative inserts 3164, 3166, 3168 are embodied as rectangularblocks, but may have other configurations in other embodiments.

Each of the inserts 3164, 3166, 3168 includes a cutting guide 3174,3176, 3178, respectively, defined therethrough. The cutting guides 3174,3176, 3178 are defined in a different location in each of the inserts3164, 3166, 3168 with respect to each other. For examples, as shown inFIG. 84, the cutting guide 3174 of the cutting guide insert 3164 islocated in a neutral, central, or non-offset position relative to theinsert 3164. However, the cutting guide 3176 of the cutting guide insert3166 is offset from the center of the cutting guide insert 3166.Additionally, the cutting guide 3178 of the cutting guide insert 3168 isoffset from the center of the cutting guide insert 3168 an amountgreater than the cutting guide 3176 of the insert 3166. The cuttingguides 3176, 3178 may be offset by any amount. In one particularembodiment, the cutting guide 3176 is offset from the center of thecutting guide insert 3166 by about two millimeters and the cutting guide3178 is offset from the center of the cutting guide insert 3168 by aboutfour millimeters. Additionally, any number of cutting guide insertshaving a variety of offset cutting guides may be used in otherembodiments.

In use, the cutting block 3150 is configured to be coupled to apatient's bone 3170, such as the femur or tibia. Again, because thebone-contacting surface 3154 of the cutting block 3150 includes negativecontour 3158, the block 3150 may be coupled to the bone 3170 in apre-planned, unique position. The cutting block 3150 may be secured tothe bone 3170 via use of a number of guide pins (not shown) received inthe pin guides 3160 and the bone 3170. Any one of the cutting guideinserts 3164, 3166, 3168 may be inserted into the aperture 3162 of thecutting block 3150. For example, the cutting guide insert 3164 having anon-offset cutting guide 3174 may be inserted into the aperture 3162 toresect the pre-planned amount of bone. That is, the bone cut made usingthe cutting guide 3164 corresponds to the cutting plane determinedduring the fabrication of the cutting block 3150 (see process step 24 ofalgorithm 10 described above in regard to FIG. 1).

However, the orthopaedic surgeon may make an intra-operative decisionbased on analysis of the bony anatomy of the patient and/or soft tissuecomplex to remove more or less of the patient's bone with respect to thepre-planned amount (i.e., the amount removed if the surgeon uses thecutting guide insert 3164). For example, the orthopaedic surgeon may usethe cutting guide insert 3166 to remove more (or less) of the patient'sbone or the cutting guide insert 3168 to remove even more (or even less)of the patient's bone.

Each cutting guide insert 3166, 3168 having an offset cutting guide3176, 3178 may be inserted into the aperture 3162 in one of twoconfigurations such that the cutting guide insert 3166, 3168 isconfigured to remove more or less of the patient's bone 3170 relative tothe non-offset cutting guide insert 3164. For example, as illustrated inFIG. 85, the cutting guide insert 3168 may be inserted into the aperture3162 in a first orientation such that any bone resectioning performedusing the cutting block 3150 will remove more bone (e.g., about fourmillimeters more) relative to the non-offset cutting guide insert 3164.Alternatively, as illustrated in FIG. 86, the cutting guide insert 3168may be removed from the aperture 3162 and re-inserted in a secondorientation such that any bone resectioning performed using the cuttingblock will remove less bone (e.g., about four millimeters less) relativeto the non-offset cutting guide insert 3164. Accordingly, theorthopaedic surgeon may resect up to about four millimeters less or morebone relative to the non-offset cutting guide insert 3164 in someembodiments. As such, it should be appreciated that the cutting block3150 provides an amount of intra-operative adjustability to theorthopaedic surgeon. In some embodiments, the orthopaedic surgeon may beprovided with the cutting block 3150 and a selection of various cuttingguide inserts to provide a wide range of adjustability.

Referring now to FIG. 87, in one embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as acutting block 3200. The cutting block 3200 is configured to be coupledto a bone, such as femur or tibia, of a patient. The cutting block 3200includes a body 3202 having a bone-contacting or bone-facing surface3204 and an outer surface 3206. The bone-contacting surface 3204includes a negative contour (not shown) configured to receive a portionof the patient's bone having a corresponding contour. As discussedabove, the negative contour of the bone-contacting surface 3204 allowsthe positioning of the cutting block 3200 on the patient's bone in aunique pre-determined location and orientation.

The cutting block 3200 also includes a number of pin guides 3210. Inuse, the pin guides 3210 are used as drill guides to establish guide pinholes in the bone of the patient for securing a number of guide pins(not shown) to the bone. The cutting block 3200 may then be coupled andsecured to the patient's bone via the guide pins.

The cutting block 3200 also includes an aperture 3212 defined in theouter surface 3206 of the body 3202. An adjustable cutting guide 3214 ispositioned in the aperture 3212. The adjustable cutting guide 3214 isoperably coupled to a thumbwheel, dial, or other positioning device 3216via a mechanical linkage 3218. In some embodiments, the cutting block3200 may include indicia 3220 located toward the side of the aperture3212 and configured to provide a visual indication of the position ofthe adjustable cutting guide 3214.

In use, the cutting block 3200 is configured to be coupled to apatient's bone 3230, such as the femur or tibia. Again, because thebone-contacting surface 3204 of the cutting block 3200 includes thenegative contour, the block 3200 may be coupled to the bone 3230 in apre-planned, unique position. The cutting block 3200 may be secured tothe bone 3230 via use of a number of guide pins (not shown) received inthe pin guides 3210 and the bone 3230. After the cutting block 3200 hasbeen secured to the patient's bone 3230, the orthopaedic surgeon mayresect the bone 3230. The amount of resection may be adjusted by thesurgeon intra-operatively via the thumbwheel 3216. That is, theorthopaedic surgeon may adjust the position of the adjustable cuttingguide 3214 in the aperture 3212, as indicated by the direction arrow3222, by operating the thumbwheel 3216. For example, the surgeon mayadjust the cutting guide 3214 to remove more or less of the patient'sbone 3230. The surgeon may monitor the position of the cutting guide3214 based on the indicia 3220.

Referring now to FIG. 88, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as acutting block 3250. The cutting block 3250 is configured to be coupledto a bone, such as femur or tibia, of a patient. The cutting block 3250includes a body 3252 having a bone-contacting or bone-facing surface3254 and an outer surface 3256. The bone-contacting surface 3254includes a negative contour 3258 configured to receive a portion of thepatient's bone having a corresponding contour. As discussed above, thenegative contour 3258 of the bone-contacting surface 3254 allows thepositioning of the cutting block 3250 on the patient's bone in a uniquepre-determined location and orientation.

The cutting block 3250 also includes a number of pin guides 3260. Inuse, the pin guides 3260 are used as drill guides to establish guide pinholes in the bone of the patient for securing a number of guide pins(not shown) to the bone. The cutting block 3250 may then be coupled andsecured to the patient's bone via the guide pins. The cutting block 3250also includes a cutting guide 3262. Illustratively, the cutting guide3262 is a captured cutting guide, but may be embodied as a non-capturedor open cutting guide in other embodiments.

The cutting block 3250 also includes a pair of threaded apertures 3264defined in an end wall of the body 3252. A pair of threaded bolts 3266are received in the apertures 3264. The threaded bolts 3266 each includea handle 3268 usable to adjust the position of the respective bolt 3266with respect to the body 3252 of the cutting block 3250. That is, eachbolt 3266 may be separately threaded into or out of the block 3250. Thethreaded apertures 3264 extend through the block such that the ends ofthe bolts 3266 opposite the handles 3268 may contact the bone 3270 ofthe patient when threaded into the body 3252 a sufficient amount.

In use, the cutting block 3250 is configured to be coupled to apatient's bone 3270, such as the femur or tibia. Again, because thebone-contacting surface 3254 of the cutting block 3250 includes thenegative contour 3258, the block 3250 may be coupled to the bone 3270 ina pre-planned, unique position. The cutting block 3250 may be secured tothe bone 3270 via use of a number of guide pins (not shown) received inthe pin guides 3260 and the bone 3270. After the cutting block 3250 hasbeen secured to the patient's bone 3270, the orthopaedic surgeon maymake an intra-operative decision based on analysis of the bony anatomyof the patient and/or soft tissue complex to adjust the position of thecutting block 3250 relative to the bone 3270. To do so, the surgeon mayoperate one or both of the threaded bolts 3266 to move the block closerto or away from the end of the bone 3270 and/or change the angulation ofthe block 3250 relative to the bone 3270. That is, the orthopaedicsurgeon may thread in or out both bolts 3266 to move the block 3250closer to or farther away from the bone 3270, respectively. Additionallyor alternatively, the orthopaedic surgeon may thread in or out only oneof the bolts 3266 to alter the valgus/varus angulation of the cuttingblock 3250 relative to the patient's bone 3270. As such, it shouldappreciated that the cutting block 3250 provides an amount ofintra-operative adjustability to the orthopaedic surgeon. It should alsobe appreciated that in some embodiments other methods of adjustabilitymay be used in addition to the bolts 3266 to provide the surgeon witheven more intra-operative adjustability.

Referring now to FIG. 89, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as acutting block 3300. The cutting block 3300 is configured to be coupledto a femur 3314 of the patient to perform resectioning on a tibia 3316of the patient. The cutting block 3300 includes a body 3302 having abone-contacting or bone-facing surface 3304 and an outer surface 3306.The bone-contacting surface 3304 includes a negative contour 3308configured to receive a portion of the patient's femur 3314 having acorresponding contour. As discussed above, the negative contour 3308 ofthe bone-contacting surface 3304 allows the positioning of the cuttingblock 3300 on the patient's femur 3314 in a unique pre-determinedlocation and orientation.

The cutting block 3300 also includes a number of pin guides 3310. Inuse, the pin guides 3310 are used as drill guides to establish guide pinholes in the bone of the patient for securing a number of guide pins(not shown) to the bone. The cutting block 3300 may then be coupled andsecured to the patient's bone via the guide pins.

The cutting block 3300 includes an extended distal wall 3320 thatextends downwardly over the tibia 3316. A tibial cutting guide 3312 isdefined in the extended distal wall 3320. Illustratively, the tibialcutting guide 3312 is a captured cutting guide, but may be embodied as anon-captured or open cutting guide in other embodiments. In use, thecutting block 3300 is configured to be coupled to a patient's femur 3314to perform a cut on the patient's tibia 3316 while the patient's knee isin flexion. Again, because the bone-contacting surface 3304 of thecutting block 3300 includes the negative contour 3308, the block 3300may be coupled to the femur 3314 in a pre-planned, unique position. Thecutting block 3300 may be secured to the femur 3314 via use of a numberof guide pins (not shown) received in the pin guides 3310 and the femur314. Because the cutting block 3300 is secured to the femur 3314, thestability of the block 3300 while performing the tibial cuts may beimproved.

Referring now to FIGS. 90-92, in another embodiment, a customizedpatient-specific orthopaedic surgical instrument 3400 includes a pair ofpaddles 3402, 3404. The paddles 3402, 3404 are substantially identicaland include an elongated shaft 3406 and a bone plate 3408. The elongatedshafts 3406 are operably coupled to a hub 3410. A handle 3412 is alsosecured to the hub 3410 to facilitate positioning of the orthopaedicsurgical instrument 3400. In some embodiments, the hub 3410 includesmechanical linkage for independently or conjointly moving each paddle3402, 3404 toward each other or away from each other as desired. Forexample, the hub 3410 may include a thumb dial usable to adjust theposition of the paddles 3402, 3404. In another embodiment, the hub 3410includes a biasing member, such as a spring, positioned between thepaddles 3402, 3404. In such embodiments, the biasing member biases thepaddles 3402, 3404 away from each other.

Each of the bone plates 3408 includes two curved arms 3414, 3416 thatwrap inwardly toward each other to form a substantially “U”-shape. Eacharm 3414, 3416 includes a condyle recess 3420 configured to receive aportion of the condyle of the femur or tibia of the patient.Additionally, each paddle 3402, 3404 of the orthopaedic surgicalinstrument 3400 includes a cutting guide 3422 secured to the respectivebone plate 3408 via a bracket 3424. The cutting guides 3422 arepivotably coupled to the bracket 3424 via a pivot hinge 3426.

Each cutting guide 3422 is independently or conjointly adjustablerelative to the respective bone plate 3408. That is, each cutting guide3422 may be pivoted to one of a number of positions relative to therespective bracket 3424. In some embodiments, an adjustment tool 3430may be used to simultaneously position each cutting guide 3422 as shownin FIG. 91. The adjustment tool 3430 includes an elongated handle 3434and two guide bars 3432 extending outwardly from the handle 3434. Theguide bars 3432 are sized and positioned relative to each other suchthat each guide bar 3432 is receivable in the guide slot of therespective cutting guide 3422. After the adjustment tool 3430 is sopositioned, the tool 3430 may be used to adjust both cutting guides 3422simultaneously by moving the tool 3430 up or down.

In some embodiments, the orthopaedic surgical instrument 3400 may bepatient-universal. However, in other embodiments, the orthopaedicsurgical instrument 3400 may be customized for a particular patient. Insuch embodiments, the orthopaedic surgical instrument 3400 may becustomized to the particular patient based on the positioning of thecondyle recesses 3416 on the bone plates 3408 and the positioning of thecutting guides 3422 (e.g., via the height of the bracket 3424).

In use, the orthopaedic surgical instrument 3400 is configured to beinserted between the patient's femur 3440 and tibia 3442 as illustratedin FIG. 92. The condyles of the patient's femur 3440 and the tibia 3442are received in the condyle recesses 3420 of the respective bone plate3408. After the instrument 3400 has been inserted between the bones3440, 3442, the paddles 3402, 3404 may be adjusted. For example, thepaddles 3402, 3404 may be moved toward or away from each other asrequired by the patient's joint and surrounding soft tissue. After thepaddles 3402, 3404 have been positioned in the desired location, each ofthe cutting guides 3422 may be positioned. To do so, the orthopaedicsurgeon may separately position each cutting guide 3422. Alternatively,the orthopaedic surgeon may use the adjustment tool 3430 tosimultaneously position each cutting guide 3422. It should beappreciated that the proximal cutting guide 3422 may be used by theorthopedic surgeon to perform femur resectioning and the distal cuttingguide 3422 may be used by the surgeon to perform tibia resectioning. Assuch, the orthopaedic surgical tool 3400 provides an amount ofadjustability to the surgeon.

Referring now to FIG. 93, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument 3500 includes a femoralcutting block 3502 and a tibial platform 3504. The femoral cutting block3502 includes a bone-contacting or bone-facing surface 3506 and an outersurface 3508. The bone-contacting surface 3506 includes a negativecontour 3510 configured to receive a portion of the patient's femur 3530having a corresponding contour. As discussed above, the negative contour3510 of the bone-contacting surface 3506 allows the positioning of thecutting block 3502 on the patient's femur 3530 in a uniquepre-determined location and orientation.

The femoral cutting block 3502 also includes a number of pin guides3512. In use, the pin guides 3512 are used as drill guides to establishguide pin holes in the femur 3530 of the patient for securing a numberof guide pins (not shown) to the femur 3530. The cutting block 3502 maythen be coupled and secured to the patient's femur 3530 via the guidepins. The cutting block 3502 also includes a cutting guide 3514.Illustratively, the cutting guide 3514 is a non-captured or open cuttingguide, which is defined by an upper wall surface of the block 3502.However, in other embodiments, the cutting guide 3514 may be embodied asa closed cutting guide.

The tibial platform 3504 includes a bone-contacting or bone-facingsurface 3516 and an upper surface 3518. In some embodiments, similar tothe bone-contacting surface 3506 of the cutting block 3502, thebone-contacting surface 3516 includes a negative contour (not shown)configured to receive a portion of the patient's tibia 3532 having acorresponding contour. In such embodiments, as discussed above, thenegative contour of the bone-contacting surface 3516 allows thepositioning of the tibial platform 3504 on the patient's tibia 3532 in aunique pre-determined location and orientation. However, in otherembodiments, the bone-contacting surface 3516 may be substantiallyplanar and configured to be positioned on a resected tibia 3532 having aplanar top surface.

The tibial platform 3504 is connected to the femoral cutting block 3502via a rod 3520. As illustrated in FIG. 93, the rod 3520 extends awayfrom the platform 3504 and the cutting block 3502 to provide additionalroom around the patient's knee joint for the orthopaedic surgeon.

Referring now to FIGS. 94 and 95, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as a5-in-1 cutting block 3550. The cutting block 3550 is configured to becoupled to a bone, such as femur or tibia, of a patient. The cuttingblock 3550 includes a generally L-shaped body 3552 having an anteriorplate 3590 and a distal plate 3592. Both of the plates 3590, 3590 have abone-contacting or bone-facing surface 3554 and an outer surface 3556.The bone-contacting surface 3554 includes a number of planar bottom orflat surfaces 3558 and a negative contour 3560 configured to receive aportion of the patient's bone having a corresponding contour. Asdiscussed above, the negative contour 3560 of the bone-contactingsurface 3554 allows the positioning of the cutting block 3550 on thepatient's bone in a unique pre-determined location and orientation. Inthe case of the anterior plate 3590, one of the flat surfaces 3558extends distally in a direction away from a proximal-most edge 3594 ofthe anterior plate 3590 and transitions to an anterior negative contour3560 that extends distally away from the flat surface 3558. The anteriornegative contour 3560 in turn transitions to another of the flatsurfaces 3558 which extends distally away from the anterior negativecontour 3560 toward the distal plate 3592. In the case of the distalplate 3592, one of the flat surfaces 3558 extends posteriorly in adirection away from the anterior plate 3590 and transitions to an distalnegative contour 3560 that extends posteriorly away from the flatsurface 3558. The distal negative contour 3560 in turn transitions toanother of the flat surfaces 3558 which extends posteriorly away fromthe distal negative contour 3560 toward a posterior-most edge 3596 ofthe distal plate 3592.

The cutting block 3550 also includes a number of pin guides 3562. Inuse, the pin guides 3562 are used as drill guides to establish guidepinholes in the bone of the patient for securing a number of guide pins3564 to the bone. The cutting block 3550 may then be coupled and securedto the patient's bone via the guide pins 3564.

The cutting block 3550 also includes five captured cutting guides 3566,3568, 3570, 3572, 3574. The illustrative cutting guide 3566 is a distalcutting guide, the cutting guide 3568 is an anterior cutting guide, andthe cutting guide 3574 is a posterior cutting guide. The cutting guides3570, 3572 are angled cutting guides. It should be appreciated that thecutting guides 3566, 3568, 3570, 3572, 3574 allow the orthopaedicsurgeon to perform up to five different bone cuts using the same cuttingblock 3550.

In use, the cutting block 3550 is configured to be coupled to apatient's bone 3550, such as the femur or tibia. Again, because thebone-contacting surface 3554 of the cutting block 3550 includes negativecontour 3560, the block 3550 may be coupled to the bone 3580 in apre-planned, unique position. The cutting block 3550 may be secured tothe bone 3580 via use of a number of guide pins 3564 received in the pinguides 3562 and the bone 3580. After the cutting block 3550 has beensecured to the patient's bone 3580 as illustrated in FIG. 94, theorthopaedic surgeon may use the block 3550 to perform any one of anumber of resections of the bone 3580 using one or more of the cuttingguides 3566, 3568, 3570, 3572, 3574.

Additionally, the cutting block 3550 may be used to perform a number ofre-cuts of the patient's bone. For example, as illustrated in FIG. 95,after the initial resectioning procedure, the orthopaedic surgeon maydetermine that additional bone must be removed from the patient's bone3580. If so, the surgeon may re-secure the cutting block 3550 to thepatient's resected bone 3580. In such a configuration, the planar bottomsurfaces 3558 of the bone-contacting surface 3554 contact or confrontthe planar resected surfaces of the patient's bone. As such, the planarbottom surfaces 3558 allow the cutting block 3550 to remain stable onthe resected bone 3580 even though the block 3550 includes the negativecontours 3560 defined in the bone-contacting surface 3554. It should beappreciated that the cutting block 3550 may be used to perform anynumber of resectioning cuts as described above. As such, the cuttingblock 3550 provides an amount of intra-operative adjustability to theorthopaedic surgeon.

In other embodiments, adjustability of the positioning and cuttingplanes of the customized patient-specific orthopaedic surgicalinstrument may be implemented using other methods. For example, in someembodiments, more than a single customized patient-specific orthopaedicsurgical instrument is designed and fabricated in process steps 24-30 ofthe algorithm 10 described above in regard to FIG. 1. That is, ratherthan a single patient-specific orthopaedic surgical instrument, two ormore patient-specific instruments may be designed, fabricated, andshipped to the orthopaedic surgeon. Each instrument may be configured togenerate different cutting planes. For example, one instrument may beused to perform a resection that is two millimeters greater or lesserthan the standard instrument. In this way, the orthopaedic surgeon maydecide pre- or intra-operatively which particular instrument to usebased on intra-operative analysis of the patient's joint and/or softtissue complex.

Additionally, in some orthopaedic surgical procedures, the surgeon mayremove the posterior cruciate ligament (PCL). In such embodiments, theflexion gap of the patient's joint may be increased. As such, thecustomized patient-specific orthopaedic instrument may be fabricated toadjust for the increased flexion gap. For example, a cutting blockconfigured to remove an additional amount of bone may be fabricated.

Further, in some embodiments, the femoral lugs of each orthopaedicimplant are positioned in the same location across the different sizesof implants. As such, the downsizing or adjustment of sizes for theorthopaedic implants may be done without the need of additionaldrilling, guide pin attachment, and/or the like.

Referring now to FIG. 96, in one embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as acutting block 4100. The cutting block 4100 is configured to be coupledto a bone, such as femur or tibia, of a patient. The cutting block 4100includes a body 4102 having a bone-contacting or bone-facing surface4104 and an outer surface 4106. The bone-contacting surface 4104includes a negative contour 4108 configured to receive a portion of thepatient's bone having a corresponding contour. As discussed above, thenegative contour 4108 of the bone-contacting surface 4104 allows thepositioning of the cutting block 4100 on the patient's bone in a uniquepre-determined location and orientation.

The cutting block 4100 also includes a number of pin guides 4110. Inuse, the pin guides 4110 are used as drill guides to establish guide pinholes in the bone of the patient for securing a number of guide pins(not shown) to the bone. The cutting block 4100 may then be coupled tothe patient's bone via the guide pins. The cutting block 4100 alsoincludes a cutting guide 4112. Illustratively, the cutting guide 4112 isembodied as a captured cutting guide, but may be embodied as anon-captured or open cutting guide in other embodiments. It should beappreciated that because the position of the cutting guide 4112 ispre-determined due to the configuration of the cutting block 4100, anybone cuts made using the patient-specific cutting block 4100 correspondto the predetermined bone cutting planes (see process step 24 ofalgorithm 10 described above in regard to FIG. 1).

Referring now to FIG. 97, in another embodiment, a customizedpatient-specific orthopaedic surgical instrument 4150 includes a cuttingblock 4152 and a leg clamp 4154. The cutting block 4152 isillustratively configured to be coupled to the patient's tibia, but maybe configured to be coupled to another bone of the patient, such as thefemur, in other embodiments. The cutting block 4152 is customized to theparticular patient and, similar to the cutting block 4100 describedabove in regard to FIG. 96, includes a bone-contacting or bone-facingsurface 4153 having a negative contour (not shown) configured to receivea portion of the patient's bone having a corresponding contour. Asdiscussed above, the negative contour of the bone-contacting surface4153 allows the positioning of the cutting block 4150 on the patient'sbone in a unique pre-determined location and orientation.

The illustrative cutting block 4152 includes a non-captured cuttingguide 4158. That is, a top surface 4156 of the cutting block 4152 isused as the cutting guide and is aligned such that the cutting planeestablished using the cutting block 4152 corresponds to the cuttingplane determined in process step 24 of the algorithm 10 described abovein regard to FIG. 1. Additionally, the illustrative cutting block 4152is positioned such that the block 4152 extends around the medial side ofthe patient's bone a distance greater than the distance that the block4152 extends around the lateral side of the patient's bone. However, inother embodiments, the block 4152 may be aligned in a different manner.The cutting block 4152 may or may not be secured to the patient's bone.For example, in one embodiment, the cutting block 4152 is secured to thepatient's bone via a number of guide pins similar to the cutting block4100 described above in regard to FIG. 96.

The cutting block 4152 is coupled to the leg clamp 4154 via a rod 4160,which extends out of the incision site 4162 of the patient's leg. Therod 4160 is configured such that the clamp 4154 may be secured to thepatient's leg. The clamp 4154 may be made from any suitable materialand, in one particular embodiment, is disposable. For example, the clamp4154 may be formed from a plastic material and secured to the patient'sleg via use of a securing device such as a hook-and-loop device.Additionally, in some embodiments, the clamp 4154 is adjustable to fit anumber of different leg sizes. However, in other embodiments, the clamp4154 may be patient-specific and designed to fit the leg of theparticular patient.

In use, the cutting block 4152 of the customized patient-specificorthopaedic surgical instrument 4150 is inserted into the incision site4162 and, in some embodiments, secured to the patient's bone via anumber of guide pins. The clamp 4154 is secured to the patient's legusing the securing device, such as a hook-and-loop mechanism. It shouldbe appreciated that because the cutting block 4152 is secured to thepatient's leg via the clamp 4154, the stability of the block 4152 may beincreased.

Referring now to FIG. 98, in another embodiment, a customizedpatient-specific orthopaedic surgical instrument 4200 includes a cuttingblock 4202 and a brace 4204. Similar to the cutting block 4150 describedabove in regard to FIG. 97, the cutting block 4202 is illustrativelyconfigured to be coupled to the patient's tibia 4206, but may beconfigured to be coupled to another bone of the patient, such as thefemur 4208, in other embodiments. The cutting block 4202 is customizedto the particular patient and, similar to the cutting block 4100described above in regard to FIG. 96, includes a bone-contacting orbone-facing surface 4210 having a negative contour (not shown)configured to receive a portion of the patient's bone having acorresponding contour. As discussed above, the negative contour of thebone-contacting surface 4210 allows the positioning of the cutting block4202 on the patient's bone in a unique pre-determined location andorientation.

The illustrative cutting block 4202 includes an non-captured cuttingguide 4212 similar to the cutting block 4152 described above. That is, atop surface of the cutting block 4202 is used as the cutting guide andis aligned such that the cutting plane established using the cuttingblock 4202 corresponds to the cutting plane determined in process step24 of the algorithm 10 described above in regard to FIG. 1. The cuttingblock 4202 includes a number of pin guides 4214, which facilitate thecoupling of the cutting block 4202 to the tibia 4206 via a number ofguide pins.

The brace 4204 of the instrument 4200 includes an arm 4216, whichextends from the cutting block 4202 and out of the incision site 4222 ofthe patient's leg. The brace 4204 also includes a bone support 4218coupled to the arm 4216. The bone support 4218 includes two inwardlyextending flanges 4220. The bone support 4218 is configured to receiveor otherwise be supported by the apex of the patient's tibia 4206 toprovide an amount of stability to the cutting block 4202. As such, thearm 4216 may extend from the cutting block 4202 any suitable distancesuch that the bone support 4218 is positioned to engage the tibial apex.

Referring now to FIG. 99, in another embodiment, a customizedpatient-specific orthopaedic surgical instrument 4250 includes a cuttingblock 4252 and a brace 4254. Similar to the cutting block 4200 describedabove in regard to FIG. 98, the cutting block 4252 is illustrativelyconfigured to be coupled to the patient's tibia, but may be configuredto be coupled to another bone of the patient, such as the femur, inother embodiments. The cutting block 4252 is customized to theparticular patient and, similar to the cutting block 4100 describedabove in regard to FIG. 96, includes a bone-contacting or bone-facingsurface 4256 having a negative contour (not shown) configured to receivea portion of the patient's bone having a corresponding contour. Asdiscussed above, the negative contour of the bone-contacting surfaceallows the positioning of the cutting block 4252 on the patient's bonein a unique pre-determined location and orientation.

The illustrative cutting block 4250 includes a non-captured cuttingguide 4258 similar to the cutting block 4202 described above. That is, atop surface of the cutting block 4250 is used as the cutting guide andis aligned such that the cutting plane established using the cuttingblock 4252 corresponds to the cutting plane determined in process step24 of the algorithm 10 described above in regard to FIG. 1. The cuttingblock 4252 also includes a number of pin guides 4260, which facilitatethe coupling of the cutting block 4202 to the tibia via a number ofguide pins.

The brace 4254 of the instrument 4250 includes an arm 4262, whichextends from the cutting block 4252 and out of the incision site 4268 ofthe patient's leg. The brace 4254 also includes a flat flange 4264coupled to the arm 4262. The flange 4264 is positioned to besubstantially parallel to the patient's tibia and includes a number ofapertures 4266 defined therethrough. The flange 4264 is secured to thepatient's tibia via a number of percutaneous pins or screws 4270 thatare received in the aperture 4266. It should be appreciated that becausethe flange 4264 is secured to the patient's bone, the stability of thecutting block 4252 may be increased.

Referring now to FIG. 100, in another embodiment, a customizedpatient-specific orthopaedic surgical instrument 4300 includes apatient-specific cutting block 4302 and an alignment rod 4304. Thecutting block 4302 is configured to be coupled to a bone of the patientsuch as, for example the patient's tibia or femur. Similar to thecutting blocks 4152, 4202, 4252 described above, the cutting block 4302is customized to the particular patient and includes a bone-contactingor bone-facing surface 4306 having a negative contour (not shown)configured to receive a portion of the patient's bone having acorresponding contour. As discussed above, the negative contour of thebone-contacting surface 4306 allows the positioning of the cutting block4302 on the patient's bone in a unique pre-determined location andorientation.

In some embodiments, the cutting block 4302 may include a capturedcutting guide. Additionally or alternatively, the cutting block 4302 mayinclude a non-captured cutting guide. The cutting block 4302 may or maynot be configured to be secured to the patient's bone. For example, insome embodiments, the cutting block may include a number of pin guidesto facilitate the securing of the cutting block 4302 to the patient'sbone via a number of guide pins (not shown).

The cutting block 4302 is coupled to the alignment rod 4304 via ahorizontal bar 4310, which extends out of the incision site 4308. In theillustrative embodiment, the horizontal bar 4310 is integral to thealignment rod 4304. The alignment rod 4304 includes an upper rod 4312and a lower rod 4314 having a diameter smaller than the diameter of theupper rod 4312. In the illustrative embodiment, the lower rod 4314 is atelescoping rod and is configured to be retracted into and extended fromthe upper rod 4312 such that the overall length of the alignment rod4314 is adjustable. In other embodiments, the upper rod 4312 may be atelescoping rod and configured to be retracted into and extended fromthe lower rod 4314. In the illustrative embodiment, the position of thelower rod 4314 relative to the upper rod 4312 may be fixed via use of asecuring device 4316. The securing device 4316 may be embodied as athumbscrew or other securing device capable of securing the lower rod4314 in a fixed position relative to the upper rod 4312.

The alignment rod 4304 also includes an ankle brace 4318 configured tobe secured to the ankle of the patient. The ankle brace extends from thelower rod 4314 in a substantially orthogonal orientation and includes arear strap or clamp 4320. The rear strap 4320 is configured to securethe patient's ankle to the ankle brace 4318. In some embodiments, therear strap 4320 is removable from the ankle brace 4318 to allow thepatient's ankle to be received therein.

In use, the cutting block 4302 may be coupled to the patient's bone viathe guide pins. The lower rod 4314 may be extended from or retractedinto the upper rod 4312 to adjust the overall length of the alignmentrod 4304 to the length of the patient's leg. After the alignment rod hasbeen adjusted, the ankle brace 4318 may be secured to the patient'sankle. It should be appreciated that in use the alignment rod 4304 maybe positioned to target the center of the patient's ankle to align thecutting block 4302 accordingly.

Referring now to FIG. 101, in another embodiment, a customizedpatient-specific orthopaedic surgical instrument 4350 includes apatient-specific cutting block 4352 and an alignment device 4354. Thecutting block 4352 is configured to be coupled to a bone of the patientsuch as, for example the patient's tibia or femur. Similar to thecutting blocks 4152, 4202, 4252 described above, the cutting block 4352is customized to the particular patient and includes a bone-contactingsurface 4356 having a negative contour (not shown) configured to receivea portion of the patient's bone having a corresponding contour. Asdiscussed above, the negative contour of the bone-contacting surface4356 allows the positioning of the cutting block 4352 on the patient'sbone in a unique pre-determined location and orientation.

In some embodiments, the cutting block 4352 may include a capturedcutting guide. Additionally or alternatively, the cutting block 4352 mayinclude a non-captured cutting guide. The cutting block 4352 may or maynot be configured to be secured to the patient's bone. For example, insome embodiments, the cutting block may include a number of pin guidesto facilitate the securing of the cutting block 4352 to the patient'sbone via a number of guide pins (not shown).

As shown in FIG. 101, the instrument 4350 includes an extension rod 4358coupled to the cutting block 4352 and extending out of the incision site4360. Illustratively, the extension rod 4358 is substantially straight.The alignment device 4354 is secured to an end 4366 of the extension rod4358. The alignment device 4354 includes a tensioner 4362, such as aweight, coupled to the end 4366 via a cord 4364. In other embodiments,the orthopaedic surgeon may apply a downward force on the cord 4364 inplace of the tensioner 4362.

In use, the cutting block 4352 may be coupled to the patient's bone viathe guide pins. In so doing, the position of the cord 4364 and thetensioner 4362 relative to the patient's leg may be used to align thecutting block 4352 accordingly. Once so aligned, the cord 4364 andtensioner 4362 may be removed from the cutting block 4352 if so desired.

Referring now to FIGS. 102 and 103, in another embodiment, thecustomized patient-specific orthopaedic surgical instrument may beembodied as a cutting block 4400. The cutting block 4400 is configuredto be coupled to a bone 4410 of the patient. The cutting block 4400 isillustratively a tibial cutting block, but may be configured for usewith other bones, such as the femur, in other embodiments. The cuttingblock 4400 includes a bone-contacting or bone-facing surface 4402 and anouter surface 4404. The bone-contacting surface 4402 includes a negativecontour 4406 (see FIG. 103) configured to receive a portion of thepatient's bone having a corresponding contour. As discussed above, thenegative contour 4406 of the bone-contacting surface 4402 allows thepositioning of the cutting block 4400 on the patient's bone 4410 in aunique pre-determined location and orientation.

The cutting block 4400 includes a cutting guide 4412. Illustratively,the cutting guide 4412 is a captured cutting guide, but may be embodiedas a non-captured or open cutting guide in other embodiments. It shouldbe appreciated that because the position of the cutting guide 4412 ispre-determined due to the configuration of the cutting block 4400, anybone cuts made using the patient-specific cutting block 4400 correspondto the predetermined bone cutting planes (see process step 24 ofalgorithm 10 described above in regard to FIG. 1).

The cutting block 4400 also includes a number of pin guides 4414. Thepin guides 4414 are angled relative to the outer surface 4404 of theblock 4400. The location and angulation of the pin guides 4414 iscustomized to the particular patient such that when the cutting block iscoupled to the patient's bone 4410, a number of guide pins 4416 may beinserted into the pin guides 4414. When so position, a portion of eachguide pin 4416 extends from the bone-contacting surface 4402. The guidepins 4416 are so positioned such that guide pins contact the surface ofthe bone 4410. For example, in one particular embodiment, the pin guides4414 are configured such that the bone 4410 of the patient is wedgedbetween the guide pins 4416 when the pins 4416 are inserted into theguides 4414. It should be appreciated that is use the contact betweenthe guide pins 4416 and the patient's bone may increase the stability ofthe cutting block 4400.

In some embodiments, the cutting block 4400 may also include other pinguides (not shown) to facilitate the coupling of the cutting block 4400to the patient's bone 4410. That is, a number of guide pins may beinserted into the additional guides to secure the cutting block 4400 tothe tibia 4410 as discussed above. Additionally, in some embodiments,the cutting block 4400 may include an alignment rod 4418 extendingdownwardly therefrom. In use, an orthopaedic surgeon may use thealignment rod 4418 to reference the orientation of the cutting block4400 relative to the patient's bone 4410. For example, the alignment rod4418 may be used to reference the anterior/posterior angulation of thecutting block 4400.

Referring now to FIG. 104, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as acutting block 4450. The cutting block 4450 is configured to be coupledto a bone 4464 of the patient. The cutting block 4450 is illustrativelya tibial cutting block, but may be configured for use with other bones,such as the femur, in other embodiments. The cutting block 4450 includesa bone-contacting or bone-facing surface 4452 and an outer surface 4454.The bone-contacting surface 4452 includes a negative contour 4456configured to receive a portion of the patient's bone having acorresponding contour. As discussed above, the negative contour 4456 ofthe bone-contacting surface 4452 allows the positioning of the cuttingblock 4450 on the patient's bone 4464 in a unique pre-determinedlocation and orientation.

The cutting block 4450 includes a cutting guide 4468. Illustratively,the cutting guide 4468 is a captured cutting guide, but may be embodiedas a non-captured or open cutting guide in other embodiments. It shouldbe appreciated that because the position of the cutting guide 4468 ispre-determined due to the configuration of the cutting block 4450, anybone cuts made using the patient-specific cutting block 4450 correspondto the predetermined bone cutting planes (see process step 24 ofalgorithm 10 described above in regard to FIG. 1). In some embodiments,the cutting block 4450 may also include a number of pin guides (notshown). As discussed above, the pin guides may be used to facilitate thecoupling of the cutting block 4450 to the patient's bone 4464 via use ofa number of corresponding guide pins (not shown).

The cutting block 4450 also includes a post 4460 extending from thebone-contacting surface 4456. The post 4460 is configured to be receivedin an aperture 4462 formed in the patient's bone 4464. The aperture 4462may be defined in the patient's tibia or bone 4464 via use of anorthopaedic drill or the like. The position of the aperture 4462 may becustomized to the particular patient. Additionally, the position of theaperture 4462 may be standardized relative to the particular type ofbone being resected. After the aperture 4462 is formed, a number ofvarious orthopaedic instruments may use the aperture 4462 as a commonguide or guide point. For example, in use, the illustrative cuttingblock 4450 is configured to be coupled to the patient's tibia 4464 suchthat the post 4460 is received in the aperture 4462. In someembodiments, as discussed above, the cutting block 4450 may also besecured to the bone 4464 via a number of guide pins. The patient's bone4464 may then be resected. It should be appreciated that when the post4460 is received in the aperture 4462, the stability of the cuttingblock 4450 may be increased.

Referring now to FIGS. 105 and 106, in another embodiment, thecustomized patient-specific orthopaedic surgical instrument may beembodied as a tibial cutting block 4500. The tibial cutting block 4500is configured to be coupled to a tibia 4502 of the patient. The tibialcutting block 4500 includes a body 4504 having a tubercle-receivingclamp 4506. The clamp 4506 includes two arms 4508 that extend downwardlyfrom the body 4504. The cutting block 4500 also includes a flange 4510defined at an end of the body 4504 opposite the clamp 4506.

The cutting block 4500 also includes a captured cutting guide 4512. Thecutting guide 4512 extends from a side of the body 4504. Illustratively,the cutting guide 4512 is curved such that the guide 4512 wraps around aportion of the tibia 4502. The clamp 4506 is customized to theparticular patient's bony anatomy such that the position of the cuttingguide 4512 relative to the tibia 4502 is predetermined. It should beappreciated that because the position of the cutting guide 4512 ispredetermined, any bone cuts made using the patient-specific cuttingblock 4500 correspond to the predetermined bone cutting planes (seeprocess step 24 of algorithm 10 described above in regard to FIG. 1). Insome embodiments, the cutting block 4500 may also include a number ofpin guides (not shown). As discussed above, the pin guides may be usedto facilitate the coupling of the cutting block 4500 to the patient'sbone 4502 via use of a number of corresponding guide pins (not shown).

In use, as shown in FIG. 106, the cutting block 4500 is secured to thepatient's tibia 4502 by impacting the cutting block 4500 onto the bone4502 such that the tibial tubercle 4514 of the patient's tibia 4502 isreceived in the clamp 4506. To do so, an orthopaedic hammer or otherimpacting device may be used to apply an amount of downward force on theflange 4510 of the block 4500. The cutting block 4500 is secured to thepatient's bone 4502 via the clamp 4506.

Referring now to FIGS. 107 and 108, in another embodiment, thecustomized patient-specific orthopaedic surgical instrument may beembodied as a tibial cutting block 4550. The tibial cutting block 4550is configured to be coupled to a tibia 4502 of the patient. The tibialcutting block 4550 includes a body 4554 having a bone-contacting orbone-facing surface 4556 and an outer surface 4558. The bone-contactingsurface 4556 includes a negative contour 4560 configured to receive aportion of the patient's bone having a corresponding contour. Asdiscussed above, the negative contour 4560 of the bone-contactingsurface 4556 allows the positioning of the cutting block 4550 on thepatient's bone 4502 in a unique pre-determined location and orientation.

The cutting block 4550 includes a cutting guide 4562. Illustratively,the cutting guide 4562 is a captured cutting guide, but may be embodiedas a non-captured or open cutting guide in other embodiments. It shouldbe appreciated that because the position of the cutting guide 4562 ispre-determined due to the configuration of the cutting block 4550, anybone cuts made using the patient-specific cutting block 4550 correspondto the predetermined bone cutting planes (see process step 24 ofalgorithm 10 described above in regard to FIG. 1). In some embodiments,the cutting block 4550 may also include a number of pin guides (notshown). As discussed above, the pin guides may be used to facilitate thecoupling of the cutting block 4550 to the patient's bone 4502 via use ofa number of corresponding guide pins (not shown).

The cutting block 4550 also includes a pair of tabs 4564 that extendfrom an upper side 4566 of the body 4564 of the cutting block 4550. Thetabs 4564 are spaced apart to define an open area 4568 therebetween.Additionally, the tabs 4564 are curved when viewed in the medial/lateralplane. In use, the cutting block 4550 is coupled to the patient's tibia4502 such that the tabs 4564 are received between the tibia 4502 and theposterior condyles of the patient's femur 4570 when the patient's kneeis in flexion. In such a position, the tabs 4564 are secured in place bythe joint force between the femur 4570 and the tibia 4502. In should beappreciated that by securing the tabs 4564 between the femur 4570 andthe tibia 4502, the stability of the cutting block 4550 may be improved.Additionally, in some embodiments, the cutting block 4550 may be securedto the tibia 4502 via use of guide pins for further stability.

Referring now to FIGS. 109 and 110, in another embodiment, thecustomized patient-specific orthopaedic surgical instrument may beembodied as a cutting block 4600. The cutting block 4600 is configuredto be coupled to a bone 4602 of the patient. For example, the cuttingblock 4600 may be configured to be coupled to a tibia, femur, or otherbone of the patient. The cutting block 4600 includes a bone-facingsurface 4604 and an outer surface 4606. The illustrative cutting block4600 includes a non-captured cutting guide 4608, but may include acaptured cutting guide in other embodiments. The non-captured cuttingguide 4608 is defined by a side surface 4610 of the cutting block 4600.In use, an orthopaedic surgeon may use the surface 4610 as a guide forthe cutting blade of a bone saw or the like.

The cutting block 4600 also includes a number of guide pins 4612. Theguide pins 4612 extend from the bone-facing surface 4604 of the block4600. Each of the guide pins 4612 extend from the bone-facing surface4604 a particular length. The length of each guide pin 4612 isdetermined based on the particular bony anatomy of the patient. That is,the length of the guide pins 4612 is selected such that the cuttingblock 4600 is patient-specific. Additionally, length of the guide pins4612 allows the positioning of the cutting block 4600 in apre-determined location and orientation relative to the bone 4602.

In use, the cutting block 4600 is coupled to the patient's bone 4602 asillustrated in FIG. 110. Again, the guide pins 4612 are designed to havea length such that the end 4614 of each pin 4612 contacts the surface ofthe bone 4602. In some embodiments, an amount of form-fitting, hardeningmaterial 4616 may be positioned between the cutting block 4600 and thepatient's bone 4602 to further stabilize the cutting block 4600. Thematerial 4616 may be embodied as any type of form-fitting material suchas, for example, dental plaster, configured to hardened after a set-upperiod. In some embodiments, the material 4616 is positioned in aformable container such as a bag or the like.

Referring now to FIGS. 111 and 112, in another embodiment, a customizedpatient-specific orthopaedic surgical instrument 4650 includes a cuttingblock 4652 and a clamp 4654 coupled to the block 4652. The cutting block4652 is configured to be coupled to a bone 4656 of the patient, such asthe tibia or femur. The cutting block 4652 includes a bone-contacting orbone-facing surface 4658 and an outer surface 4660 (see FIG. 112). Thebone-contacting surface 4658 includes a negative contour 4662 configuredto receive a portion of the patient's bone 4656 having a correspondingcontour. As discussed above, the negative contour 4662 of thebone-contacting surface 4658 allows the positioning of the cutting block4652 on the patient's bone 4656 in a unique pre-determined location andorientation.

The cutting block 4652 also includes a cutting guide 4664.Illustratively, the cutting guide 4664 is a captured cutting guide, butmay be embodied as a non-captured or open cutting guide in otherembodiments. It should be appreciated that because the position of thecutting guide 4664 is pre-determined due to the configuration of thecutting block 4652, any bone cuts made using the patient-specificcutting block 4652 correspond to the predetermined bone cutting planes(see process step 24 of algorithm 10 described above in regard to FIG.1).

The clamp 4654 includes a base 4666 received on a threaded rod 4668. Thebase 4666 of the clamp 4654 is coupled to the cutting block 4652 via thethreaded rod 4668. A handle 4670 is secured to the threaded rod 4668 atan end opposite the block 4652. The clamp 4654 also includes a pair ofhooks or arms 4672 coupled to the base 4666. The hooks 4672 areconfigured to pivot with respect to the base 4666.

In use, the cutting block 4652 is configured to be coupled to the bone4656 of the patient. The cutting block 4652 is secured to the bone 4656via the clamp 4654. To do so, the hooks 4672 are positioned around thebone 4656 as illustrated in FIG. 112. The handle 4670 may then beoperated (i.e., twisted in the appropriate direction) to cause the base4666 of the clamp 4654 to be moved away from the cutting block 4652. Asthe base 4666 of the clamp 4654 is moved away from the block 4652, thehooks 4672 contact the bone 4656. As such, the cutting block 4652 may besecured to the bone 4656 by tightening the clamp 4654 in theabove-described manner. Although described as being positioned aroundthe bone 4656, the clamp 4654 may be configured to be positioned aroundthe outside of the patient's leg. That is, in some embodiments, thehooks 4672 of the clamp 4654 may be positioned around the skin of thepatient's leg. In such embodiments, the hooks 4672 engage the patient'sskin when the clamp 4654 is tightened.

The hooks 4672 may have any one of a number of different configurationsin other embodiments. For example, as illustrated in FIG. 113, each ofthe hooks 4672 may include a post 4674 defined at the end 4676 of thehook 4672. Each post 4674 includes a threaded aperture 4675 definedtherethrough. A threaded pin 4678 is received in each threaded aperture4675. Each threaded pin 4678 includes a pointed end 4679 configured tocontact the patient's bone 4656 or skin during use. The position of thethreaded pin 4678 relative to the hook 4672 may be adjusted by threadingthe pin 4678 into or out of the threaded aperture 4675. As such, thehooks 4672 may be positioned around the patient's bone 4656 or skin,depending on the embodiment, and the pins 4678 may be threaded into aposition such that the pins 4678 engage the bone 4656 or skin to securethe clamp 4654 to the patient's leg.

Referring to FIG. 114, in another embodiment, each of the hooks 4672 ofthe clamp 4654 include a linkage arm 4680 and a pivotable hook 4682. Thelinkage arms 4680 are coupled to the base 4666 and are configured topivot with respect thereto. The hooks 4682 are coupled to the respectivelinkage arms 4680 via a hinge 4683. The hooks 4682 are configured topivot with respect to the respective linkage arms 4680. In someembodiments, the pivotable hooks 4682 may include a biasing member 4684secured to the tip of the hook 4682 and extending to the base of thehook 4682. The biasing member 4684 may be formed from a metallicmaterial in some embodiments. The biasing member 4684 is configured tobend or otherwise deform when the clamp 4654 is coupled to patient'sbone 4656 or leg to reduce the likely hood that the clamp 4654 damagesthe bone 4656 or skin tissue of the patient.

Referring to FIG. 115, in some embodiments, the clamp 4654 may beembodied as a halo clamp 4690. The halo clamp 4690 is configured to bepositioned around the patient's bone 4656. The halo clamp 4690 includesa number of posts 4692, each having a threaded aperture 4693 definedtherethrough. A threaded pin 4694 is received in each threaded aperture4693 and includes a pointed end 4695. The pointed ends 4695 of the pins4694 are configured to contact the patient's bone 4656 when the haloclamp 4690 is coupled to the bone 4656. The position of the threadedpins 4694 relative to the halo clamp 4690 may be adjusted by threadingthe pins 4694 into or out of the threaded apertures 4693.

In use, the halo clamp 4690 is configured to be positioned around thepatient's bone 4656 and secured thereto via the threaded pins 4694. Todo so, the threaded pins 4694 may be threaded into the respective posts4692 until each pin contacts the bone 4656 of the patient with enoughforce to secure the halo clamp 4690 thereto. In one particularembodiment, the halo clamp 4690 is configured such that the center ofmass of the bone 4656 is located at or near the center of the halo clamp4690. That is, the customized patient-specific orthopaedic surgicalinstrument 4650 is designed such that the cutting block 4652 isconfigured to be positioned in the desired position, as determined inthe process steps 24, 26 of the algorithm 10 described above in regardto FIG. 1, when the halo clamp 4690 is coupled to the bone 4656 in sucha position that the center of mass of the bone is at or near the centerof the halo clamp 4690. The center of mass of the bone may be determinedby, for example, analysis of the medical images generated in processstep 12 of the algorithm 10.

Referring now to FIG. 116, in some embodiments, a leg brace 4700 may becoupled to a patient's leg 4706 during the generation of the medicalimages in the process step 12 of the algorithm 10 described above inregard to FIG. 1. The leg brace 4700 includes a medial support rod 4702and a lateral support rod 4704. In some embodiments, the shape of therods 4702, 4704 may be customized for the particular patient. That is,the rods 4702, 4704 may be shaped such that the rods 4702, 4704 define anegative contour configured to receive a corresponding contour of thepatient's leg 4706. However, in other embodiments, the support rods4702, 4704 may be universally shaped such that the leg brace 4700 isusable with a number of different patients. The leg brace 4700 includesan ankle clamp 4708 and a thigh clamp 4710. The ankle clamp 4708 isconfigured to be secured around the ankle area of the patient's leg 4706and the thigh clamp 4710 is configured to be secured around the thigharea of the patient's leg 4706. In some embodiments, the clamps 4708,4710 are adjustable to match the anatomy of different patients. Theclamps 4708, 4710 may be formed from a plastic or fabric material. Inuse, the leg brace 4700 may be secured to the patient's leg 4706 tostabilize the patient's leg during the generation of the medical imagessuch as during the performance of a computed tomography (CT) scan. Bystabilizing the patient's leg, the medical images produced by the imagegeneration process may be more accurate.

Referring now to FIG. 117, in some embodiments, a number of markers 5050may be secured to the relevant bone 5100 of the patient prior to thegeneration of the medical images in process step 12. The markers 5050may be embodied as pins, studs, or other devices securable to the bone5100 of the patient in a pre-operative procedure. The markers 5050 maybe secured to the bone 5100 via use of an orthopaedic drill in a mannersimilar to a guide pin, via use of a suitable adhesive such as bonecement, or the like. When so secured, a portion of each marker 5050extends outwardly from the bone 5100. Alternatively, in otherembodiments, the markers 5050 may be configured to be flush orsubstantially flush with the surface of the bone 5100. The markers 5050may be formed from any material visible in the medical image such as ametallic material. The markers 5050 are secured to the bone 5100 in thegeneral area to which the customized patient-specific orthopaedicsurgical instrument is to be coupled. For example, in one embodiment,the markers 5050 identify particular landmark features of the patient'sbone 5100. Additionally, the markers 5050 may be secured to the bone5100 in any configuration and may be embodied as any number ofindividual markers.

In some embodiments, the negative contour of the customizedpatient-specific orthopaedic surgical instrument will include recessesdesigned to receive each of the markers 5050. In embodiments wherein themarkers 5050 are substantially flush with the surface of the bone 5100,the customized patient-specific orthopaedic surgical instrument mayinclude any number of windows or the like to visually align theinstrument with the flush markers 5050. As such, the markers 5050 mayincrease the ease of positioning of the patient-specific surgicalinstrument to the bone 5100 of the patient, in particular in generallyplanar areas. After the orthopaedic surgical procedure has beenperformed by the surgeon in process step 32, the markers 5050 may beremoved from the bone of the patient. Alternatively, in someembodiments, the markers 5050 are removed after the generation of themedical images.

Referring now to FIG. 118, in some embodiments, the orthopaedic surgeonmay mark or otherwise indicate the general desired location of thecustomized patient-specific orthopaedic surgical instrument relative tothe bone 5100. For example, the orthopaedic surgeon may highlight orotherwise define a marking 5102 of the desired area in the medicalimages generated in process step 12. The orthopaedic surgeon maygenerate such an indication or highlighting using a suitable softwareapplication or via hand-drawing on hard copies of the medical images,which are subsequently sent to the vendor. The particular shape, size,and location of the marking 5102 on the bone 5100 selected by theorthopaedic surgeon may be determined based on any criteria. Forexample, in some embodiments, the location of the marking 5102 may bedetermined based on the orthopaedic surgeon's preferences, the typeand/or size of orthopaedic prosthesis to be used, the particularorthopaedic surgical procedure to be performed, and/or any othercriteria selected by the orthopaedic surgeon.

Referring now to FIG. 119, in one embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as afemoral cutting block 5150. The femoral cutting block 5150 is configuredto be coupled to a femur 5152 of the patient. The femoral cutting block5150 includes a bone-contacting or bone-facing surface 5154 and an outersurface 5156. The bone-contacting surface 5154 includes a negativecontour (not shown) configured to receive a portion of the patient'sbone having a corresponding contour. As discussed above, the negativecontour of the bone-contacting surface 5154 allows the positioning ofthe femoral cutting block 5150 on the patient's bone 5152 in a uniquepre-determined location and orientation.

The femoral cutting block 5150 also includes a number of pin guides5158. In use, the pin guides 5158 are used as drill guides to establishguide pin holes in the femur 5152 for securing a number of guide pins5160 to the bone 5152. The cutting block 5150 also includes a cuttingguide 5162. Illustratively, the cutting guide 5162 is a captured cuttingguide, but may be embodied as a non-captured or open cutting guide inother embodiments. It should be appreciated that because the position ofthe cutting guide 5162 is pre-determined due to the configuration of thefemoral cutting block 5150, any bone cuts made using thepatient-specific femoral cutting block 5150 correspond to thepredetermined bone cutting planes (see process step 24 of algorithm 10described above in regard to FIG. 1).

In use, the femoral cutting block 5150 is configured to be coupled tothe patient's femur 5152. Again, because the bone-contacting surface5154 of the femoral cutting block 5150 includes negative contour, theblock 5150 may be coupled to the femur 5152 in a pre-planned, uniqueposition. In particular, the femoral cutting block 5150 is designed andconfigured to couple to the patient's femur 5152 such that the one ormore of the guide pins 5160 are received in a corresponding fossa of thefemur 5152. For example, as illustrated in FIG. 119, the femoral cuttingblock 5150 is configured such that one of the guide pins 5160 will beinserted into the femur 5152 through a fossa 5164 of the femur 5152. Bysecuring the guide pin 5160 to the femur 5152 in the fossa 5164, thestability of the femoral cutting block 5150 on the femur 5152 may beimproved. For example, in one particular embodiment, the femoral cuttingblock 5150 is designed such that the guide pin 5160 is substantiallyperpendicular to the surface of the femur 5152 defining the fossa 5164.In some embodiments, the femoral cutting block 5150 may be designed suchthat any number of the guide pins 5160 is received in a correspondingone or more fossas of the femur 5152 to further provide stability to theblock 5150.

The femoral cutting block 5150 may be designed as described above duringthe generation of a model of the block 5150 in process step 26 of thealgorithm 10 described above in regard to FIG. 1. To do so, a suitablesoftware algorithm may be used to determine the location of the fossasof the relevant bone of the patient and design the cutting block 5150such that the guide pins 5160 of the block 5150 are received in one ormore of the fossas 5164.

Referring now to FIG. 120, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as atibial cutting block 5200. The tibial cutting block 5200 is configuredto be coupled to a tibia 5202 of the patient. Similar to the femoralcutting block 5150, the tibial cutting block 5200 includes abone-contacting or bone-facing surface 5204 and an outer surface 5206.The bone-contacting surface 5204 includes a negative contour (not shown)configured to receive a portion of the patient's bone having acorresponding contour. As discussed above, the negative contour of thebone-contacting surface 5204 allows the positioning of the tibialcutting block 5200 on the patient's bone 5202 in a unique pre-determinedlocation and orientation.

The tibial cutting block 5200 also includes a number of pin guides 5208.In use, the pin guides 5208 are used as drill guides to establish guidepin holes in the tibia 5202 for securing a number of guide pins 5210 tothe bone 5202. The cutting block 5200 also includes a cutting guide5212. Illustratively, the cutting guide 5212 is a captured cuttingguide, but may be embodied as a non-captured or open cutting guide inother embodiments. Again, it should be appreciated that because theposition of the cutting guide 5212 is pre-determined due to theconfiguration of the tibial cutting block 5200, any bone cuts made usingthe patient-specific tibial cutting block 5200 correspond to thepredetermined bone cutting planes (see process step 24 of algorithm 10described above in regard to FIG. 1).

In use, the tibial cutting block 5200 is configured to be coupled to thepatient's tibia 5202. Again, because the bone-contacting surface 5204 ofthe tibial cutting block 5200 includes negative contour, the block 5200may be coupled to the tibia 5202 in a pre-planned, unique position. Inparticular, similar to the femoral cutting block 5150, the tibialcutting block 5200 is designed to couple to the patient's tibia 5202such that the one or more of the guide pins 5210 are received in acorresponding fossa of the tibia 5202. For example, as illustrated inFIG. 120, the tibial cutting block 5200 is configured such that theguide pins 5210 will be inserted into the tibia 5202 through the medialand lateral condyles 5214 of the tibia 5202. By securing the guide pins5210 to the tibia 5202 in the condyles 5214, the stability of the tibialcutting block 5200 on the tibia 5202 may be improved. For example, inone particular embodiment, the tibial cutting block 5200 is designedsuch that the guide pins 5210 are substantially perpendicular to thesurface of the tibia 5202 defining the condoyles 5214. In someembodiments, the tibial cutting block 5200 may be designed such that anynumber of the guide pins 5200 is received in a corresponding one or morefossas or condyles of the tibia 5202 to further provide stability to theblock 5150.

Again, similar to the femoral cutting block 5150, the tibial cuttingblock 5200 may be designed as described above during the generation of amodel of the block 5200 in process step 26 of the algorithm 10 describedabove in regard to FIG. 1. To do so, a suitable software algorithm maybe used to determine the location of the fossas of the relevant bone ofthe patient and design the cutting block such that the guide pins of theblock are received in one or more of the fossas.

Referring now to FIGS. 121-123, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as acutting block 5250. The cutting block 5250 is illustratively embodied asa femoral cutting block, but may be embodied as cutting blocks for otherbones, such as the tibia, in other embodiments. The cutting block 5250includes a body 5252 having a bone-facing surface 5254 and an outersurface 5256. A number of guide pin holes 5258 are define in the body5252 of the block 5250. A guide pin 5260 is received in each guide pinhole 5258 and configured to slide through the corresponding hole 5258such that the guide pin 5260 is independently movable and positionablein any one of a number of positions relative to the body 5252. That is,each of the guide pins 5260 may be positioned such that a portion of theguide pin extends downwardly from the bone-facing surface 5254 and/orextends upwardly from the outer surface 5256 as shown in FIG. 122.

The cutting block 5250 also includes a cutting guide 5264.Illustratively, the cutting guide 5264 is a captured cutting guide, butmay be embodied as a non-captured cutting guide in other embodiments.Again, it should be appreciated that because the position of the cuttingguide 5264 is pre-determined due to the configuration of the cuttingblock 5250, any bone cuts made using the patient-specific cutting block5250 correspond to the predetermined bone cutting planes (see processstep 24 of algorithm 10 described above in regard to FIG. 1).

Additionally, the cutting block 5250 includes a securing device 5262operable to individually lock each guide pin 5260 in a particularposition relative to the cutting block 5250. That is, the guide pins5260 may be locked in a separate position relative to the cutting block5250 such that each guide pin 5260 extends downwardly from thebone-facing surface 5254 a selective equal or different distance. Assuch, the guide pins 5260 may be positioned such that thebone-contacting ends of the guide pins 5260 form a selective contour.For example, as illustrated in FIG. 122, the guide pins 5260 may bepositioned, and subsequently locked into position via the securingdevice 5262, such that the bone-contacting ends 5266 of the guide pins5260 form a negative contour that corresponds to a contour of a portionof a patients bone 5268. In such a position, a portion of each guide pinmay extend from the bone-facing surface 5254 and/or the upper surface5256. The securing device 5262 may use mechanical and/or magneticdevices to lock the guide pins 5260 in the desired position.

In use, an orthopaedic surgeon may selectively position the guide pins5260 to form a negative contour that matches a portion of the patient'sbone 5268 such that the cutting block 5250 may be positioned thereon ina unique pre-determined location and orientation. To do so, the surgeonmay use a programming device 5270 as shown in FIG. 123. The programmingdevice 5270 includes a housing 5272 having an aperture 5274 configuredto receive the cutting block 5250. The aperture 5274 is defined by abottom wall 5276 and a number of sidewalls 5278. The bottom wall 5276includes a number of holes 5280 defined therein and positioned such thateach of the guide pins 5260 of the block 5250 is received in acorresponding hole 5280 of the programming device 5270. The programmingdevice 5270 includes a push rod 5298 or other adjustment device locatedin each hole 5280. The push rods 5298 are configured and operable toselectively position the corresponding guide pin 5260 by pushing theguide pin 5260 to the desired location relative to the block 5250. Theprogramming device 5270 also includes a coupler 5282 configured toengage the securing device 5262 of the block 5250 when the block 5250 ispositioned in the aperture 5274. The coupler 5282 is configured tooperate the securing device 5262 to lock the guide pins 5260 in adesired position.

In one embodiment, the programming device 5270 includes a processor5284, a memory device 5286, an input port 5288, and one or moreactuators or motors 5290. The processor 5284 may be embodied as any typeof processor including, for example, discrete processing circuitry(e.g., a collection of logic devices), general purpose integratedcircuit(s), and/or application specific integrated circuit(s) (i.e.,ASICs). The memory device 5286 may be embodied as any type of memorydevice and may include one or more memory types, such as, random accessmemory (i.e., RAM) and/or read-only memory (i.e., ROM). The input port5288 may be embodied as any type of input port configured to receive aportable media device (not shown) such as, for example, a compact disk,a digital video disk, a Universal Serial Bus (USB) device, or otherportable media device. As such, the input port 5288 may be embodied asany type of serial port, parallel port, flash drive port, or other dataport capable of communicating with and storing data on the portablemedia device.

The processor 5284 is communicatively coupled to the memory device 5286via a number of communication links 5292 and to the input port 5288 viaa number of communication links 5294. The communication links 5292, 5294may be embodied as any type of communication links capable offacilitating communication between the processor 5284 and the memorydevice 5286 and the input port 5288, respectively. For example, thecommunication links 5292, 5294 may be embodied as any number of cables,wires, fiber optic cables, wireless signals, and/or the like.

The actuators 5290 may be embodied as any type of prime movers, andassociated control and power circuitry, capable of separatelycontrolling the push rods 5298 to individually position the guide pins5260 of the cutting block 5250. In addition, one or more of theactuators 5290 is configured to control the coupler 5282 to operate thesecuring device 5262 of the block 5250 to lock the guide pins 5260 intheir respective position. The actuators 5290 are communicativelycoupled to the processor 5284 via a number of communication links 5296.Similar to the communication links 5292, 5294, the communication links5296 may be embodied as any type of communication links capable offacilitating communication between the processor 5284 and the actuators5290. For example, the communication links 5296 may be embodied as anynumber of cables, wires, fiber optic cables, wireless signals, and/orthe like.

In use, the processor 5284 of the programming device 5270 is configuredto control the actuators 5290 to operate the push rods 5298 located inthe holes 5280 of the housing 5272. The push rods 5298 individuallyposition the guide pins 5260 of the cutting block 5250 in apredetermined position relative to the block 5250. In such apredetermined position, the ends 5266 of the guide pins 5260 form anegative contour configured to receive a predetermined portion of thepatient's bone 5268 as shown in FIG. 122. After the guide pins 5260 havebeen positioned in the desired locations, the processor 5284 may beconfigured to control one or more actuators 5290 to operate the coupler5282. In response, the coupler 5282 is configured to engage the securingdevice 5262 of the block 5250 to lock the guide pins 5260 in thepredetermined locations.

The processor 5284 may be configured to perform the above-describedactions based on a software algorithm stored in the memory device 5286.The software algorithm may be received via the input port 5288. Forexample, the software algorithm executed by the processor 5284 toposition the guide pins 5260 of the cutting block 5250 in the desired,predetermined location may be stored on a compact disk or USB device,which is coupled to the input port 5288 to download the softwarealgorithm to the programming device 5270. The software algorithm may besupplied by a vendor in some embodiments. For example, referring backthe FIG. 1, the model of the customized patient-specific orthopaedicsurgical instrument generated in process step 26 of algorithm 10 may beembodied as a software algorithm usable by the programming device 5270.The vendor may ship or otherwise transmit the software algorithm to theorthopaedic surgeon for downloading into the programming device 5270. Inresponse, the programming device 5270 configures the guide pins 5260 ofthe cutting block 5250 for use on the bone 5268 of the patient. In thisway, the cutting block 5250 is re-configurable to be a patient-specificcutting block intended for use on a particular patient.

Referring now to FIG. 124, in some embodiments, a milling machine 5300is located at a healthcare facility 5302 to facilitate the fabricationof the customized patient-specific orthopaedic surgical instrument. Thehealthcare facility 5302 may be embodied as the healthcare facility,such as hospital or the like, wherein the orthopaedic surgical procedureis to be performed. Alternatively or additionally, the healthcarefacility 5302 may be embodied as the office of the orthopaedic surgeonor other healthcare provider.

The milling machine 5300 includes a processor 5304, an input port 5306,and a mill 5310. The processor 5304 may be embodied as any type ofprocessor including, for example, discrete processing circuitry (e.g., acollection of logic devices), general purpose integrated circuit(s),and/or application specific integrated circuit(s) (i.e., ASICs). Theinput port 5306 may be embodied as any type of input port configured toreceive a portable media device (not shown) such as, for example, acompact disk, a digital video disk, a Universal Serial Bus (USB) device,or other portable media device. As such, the input port 5306 may beembodied as any type of serial port, parallel port, flash drive port, orother data port capable of communicating with and storing data on theportable media device. The processor 5304 is communicatively coupled tothe input port 5306 via a number of communication links 5308. Thecommunication links 5308 may be embodied as any type of communicationlinks capable of facilitating communication between the processor 5304and the input port 5306. For example, the communication links 5308 maybe embodied as any number of cables, wires, fiber optic cables, wirelesssignals, and/or the like.

The milling machine 5300 also includes a mill 5310 communicativelycoupled to the processor 5304 via a number of communication links 5312.Similar to communication links 5308, the communication links 5312 may beembodied as any type of communication links capable of facilitatingcommunication between the processor 5304 and the mill 5310. For example,the communication links 5312 may be embodied as any number of cables,wires, fiber optic cables, wireless signals, and/or the like. The mill5310 may be embodied as any type of mill and associated devices andcircuitry capable of fabricating a customized patient-specificorthopaedic surgical instrument from suitable material such as plasticor metal.

In use, the processor 5304 is configured to control the mill 5310 tofabricate the customized patient-specific orthopaedic surgicalinstrument. The processor 5304 may be configured to control the mill5310 based on a software algorithm received via the input port 5306. Forexample, the software algorithm executed by the processor 5304 tocontrol the mill 5310 may be received from a compact disk or USB device,which is coupled to the input port. The software algorithm may besupplied by a vendor in some embodiments. For example, referring backthe FIG. 1, the model of the customized patient-specific orthopaedicsurgical instrument generated in process step 26 of algorithm 10 may beembodied as a software algorithm usable by the milling machine 5300. Thevendor may ship or otherwise transmit the software algorithm to theorthopaedic surgeon for downloading into the milling machine 5300. Inresponse, the milling machine 5300 is configured to fabricate thecustomized patient-specific orthopaedic surgical instrument based on thesoftware algorithm instructions. In this way, the fabrication of thepatient-specific instrument is performed locally, while the design ofsuch instrument may be performed remotely with respect to the healthcarefacility 5302.

One way to facilitate such remote fabrication of the customizedpatient-specific orthopaedic surgical instrument is via use of anetwork. In such a case, an instrument request including data relevantto a specific patient is generated by the surgeon or other healthcareprovider. The instrument request may include data such as medical imagesthat depict bones of the patient such as the femur and tibia. A clientmachine 5314 associated with the surgeon or healthcare provider (e.g.,located at the healthcare facility) may be used to transmit theinstrument request to the vendor.

The vendor may include a design plan system 5316. The design plan system5316 may receive an instrument request for a design plan via the networkfrom the client machine 5314 located at, for example, the healthcarefacility 5302, generate a design plan that has been customized basedupon information of the received request, and provide the healthcarefacility 5302 with the custom design plan via the network. The designplan system 5316 may include one or more computing devices andassociated software, middleware, and/or firmware that cooperate toperform the design plan customizations.

Once the design plan is sent to the healthcare facility 5302, it istransmitted to the milling machine 5300. The milling machine then usesthe design plan to fabricate the customized patient-specific orthopaedicsurgical instrument.

While the disclosure has been illustrated and described in detail in thedrawings and foregoing description, such an illustration and descriptionis to be considered as exemplary and not restrictive in character, itbeing understood that only illustrative embodiments have been shown anddescribed and that all changes and modifications that come within thespirit of the disclosure are desired to be protected.

There are a plurality of advantages of the present disclosure arisingfrom the various features of the apparatus, system, and method describedherein. It will be noted that alternative embodiments of the apparatus,system, and method of the present disclosure may not include all of thefeatures described yet still benefit from at least some of theadvantages of such features. Those of ordinary skill in the art mayreadily devise their own implementations of the apparatus, system, andmethod that incorporate one or more of the features of the presentinvention and fall within the spirit and scope of the present disclosureas defined by the appended claims.

The invention claimed is:
 1. A method of manufacturing a customizedpatient specific orthopaedic surgical instrument, the method comprising:obtaining a plurality of two-dimensional X-ray images of one or morebones, generating a digital bone model of the one or more bones basedsolely on the two-dimensional X-ray images, planning the customizedpatient specific orthopaedic surgical instrument, and producing thecustomized patient specific orthopaedic surgical instrument, thecustomized patient specific orthopaedic surgical instrument includingone or more anchor points adapted to engage a surface of the one or morebones, wherein planning the customized patient specific orthopaedicsurgical instrument includes determining locations for the one or moreanchor points on the customized patient specific orthopaedic surgicalinstrument.
 2. The method of claim 1, wherein the one or more anchorpoints include a customized patient-specific negative contour shaped toengage the surface of the one or more bones having a matching positivecontour.
 3. The method of claim 1, wherein the one or more anchor pointsinclude one or more drill guides, each drill guide being sized toreceive to a surgical drill to establish one or more guide pin holes inthe one or more bones.
 4. The method of claim 3, wherein the each drillguide of the one or more drill guides is sized to receive a guide pin tosecure the customized patient specific orthopaedic surgical instrumentto the one or more bones.
 5. The method of claim 1, wherein thecustomized patient specific orthopaedic surgical instrument is a cuttingguide block.
 6. The method of claim 1, wherein planning the customizedpatient specific orthopaedic surgical instrument includes determininglocations for one or more drill guides in the customized patientspecific orthopaedic surgical instrument to establish one or more guidepin holes in the one or more bones, and producing the customized patientspecific orthopaedic surgical instrument includes producing thecustomized patient specific orthopaedic surgical instrument having oneor more drill guides thereon.